← Product Code [FRA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA) · K213753
# Purgo (K213753)
_Aeroclean Technologies, LLC · FRA · Jun 1, 2022 · General Hospital · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K213753
## Device Facts
- **Applicant:** Aeroclean Technologies, LLC
- **Product Code:** [FRA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA.md)
- **Decision Date:** Jun 1, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6500
- **Device Class:** Class 2
- **Review Panel:** General Hospital
## Indications for Use
Purgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pürgo is non-sterile.
## Device Story
Pūrgo is a free-standing air disinfection system for medical and home healthcare environments. It utilizes a multi-layer filter cartridge (pre-filter, activated carbon, HEPA) to capture airborne particles and microorganisms, followed by a proprietary SteriDuct chamber containing UV-C LEDs (265 nm) to neutralize remaining microbes by damaging RNA/DNA. The device includes a motor/impeller, airflow/UV sensors, and a touch panel interface. Safety features include interlock switches that prevent operation if the filter door is open or a filter is missing. Healthcare providers or patients operate the device via a touch panel to select fan speeds and monitor status. By reducing airborne bioaerosols and particles, the device aims to improve air quality in clinical and home settings.
## Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including microorganism reduction efficacy (log reduction 4.1–5.4 for various bacteria, viruses, and spores), fractional efficiency testing (99.990% at 0.1-0.2 µm), ozone emission testing, airflow performance, and laminar airflow evaluation via CFD.
## Technological Characteristics
Free-standing air purifier. Components: pre-filter, activated carbon filter, HEPA filter, SteriDuct chamber with 4 UV-C LEDs (265 nm). Connectivity: None. Power: 120V. Standards: UL 507, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEST-RP-CC001.6. Software: Basic firmware for fan control, timer, and status monitoring.
## Regulatory Identification
A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.
## Predicate Devices
- Molekule Air Pro ([K211194](/device/K211194.md))
- Molekule Air Pro RX ([K200500](/device/K200500.md))
## Submission Summary (Full Text)
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June 1, 2022
AeroClean Technologies, LLC % Rita King CEO MethodSense, Inc. One Copley Pkwy, Ste. 410 Morrisville, North Carolina 27560
Re: K213753
Trade/Device Name: Purgo Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: April 29, 2022 Received: May 2, 2022
Dear Rita King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K213753
Device Name Pūrgo
#### Indications for Use (Describe)
Purgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pürgo is non-sterile.
Purgo has been demonstrated to remove the following organisms under the following exposure conditions:
| Organism | Name | Avg. max log reduction / exposure time (min) |
|-----------------|-----------------------------------------------------|----------------------------------------------|
| Gram + Bacteria | Methicillin resistant Staphylococcus
epidermidis | 4.6 (45) at normal speed |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
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## K213753 510(k) Summary
### AeroClean Technologies, LLC.
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | AeroClean Technologies, LLC.
10455 Riverside Drive, Suite 100
Palm Beach Gardens, FL 33410 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: (919) 313-3961
Fax: (919) 313-3979 |
| Company Contact: | Richard Foster
Title: Senior Director, Quality and Regulatory Affairs
Email: rfoster@aeroclean.com
Phone: (773) 791-6198 |
| Date Prepared: | June 1, 2022 |
| Trade Name: | Pūrgo™ |
| Common Name: | Purifier, Air, Ultraviolet, Medical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 880.6500 |
| Classification Panel: | General Hospital |
| Product Code: | FRA |
### Predicate Device(s):
| | Primary Predicate | Secondary Predicate |
|---------------------------|-------------------|---------------------|
| Trade Name | Molekule Air Pro | Molekule Air Pro RX |
| 510(k) Submitter / Holder | Molekule, Inc. | Molekule, Inc. |
| 510(k) Number | K211194 | K200500 |
| Regulation Number | 21 CFR 880.6500 | 21 CFR 880.6500 |
| Classification | Class II | Class II |
| Classification Panel | General Hospital | General Hospital |
| Product Code | FRA | FRA |
The primary predicate device and secondary predicate device have not been subject to a design-related recall.
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### Device Description
Pūrgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria and viruses in air. Pūrgo may be used in medical facilities and commercial home healthcare environments. Pūrgo's main components consist of
- . LED UV-C lamps that generate irradiation to destroy microorganisms that are not filtered:
- . a proprietary SteriDuct chamber that intensifies the UV-C light to destroy microbiological material:
- . a filtration system with pre-filter, activated carbon filter, and HEPA filter;
- . a motor/impeller to move air through the filtration system:
- . sensors to monitor UV irradiance and airflow;
- . an electronic control system to power and control the device; and
- . a touch panel interface equipped with LEDs to indicate the working status of the device.
Pūrgo has several built-in safety features that will prevent operation of the filter cartridge is not in place or if the filter door is not closed. The unit also incorporates UV and airflow sensors that provide warnings to the user if the device is not performing as designed to purify air.
Pūrgo pulls air through a filter cartridge and then passes the filtered air through a chamber containing UV-C light to neutralize remaining airborne microorganisms (such as bacteria, viruses, and fungi). The filter cartridge contains a series of three filters, the first of which is a pre-filter that removes physically large particulate matter (such as dust) and protects the finer particle filters downstream. This is followed by an Activated Carbon filter. Finally, a HEPA (highefficiency particulate air) filter that removes 99.995% of the remaining airborne particles above a particle size of 0.1 µm.
Any microbes that still manage to make it through the filters, pass through the SteriDuct chamber where they are subjected to Ultraviolet Radiation at 265 nm (UV-C). UV radiation at this wavelength is particularly effective at destroying microbes. UV-C irradiation has been shown to damage the microbe's RNA and DNA genetic materials sufficiently to prevent the microbe's ability to reproduce.
After passing through the filtration and SteriDuct UV-C chamber, the purified air then exits back into the room. The exit air does not destroy laminar air flow in a typical operating room environment.
#### Indications for Use
Pūrgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Purgo is non-sterile.
Pūrgo has been demonstrated to remove the following organisms under the following exposure conditions:
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| Organism | Name | Avg. max log reduction / exposure time (min) |
|-----------------|-----------------------------------------------------|----------------------------------------------|
| Gram + Bacteria | Methicillin resistant Staphylococcus
epidermidis | 4.6 (45) at normal speed |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
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## Summary of Technological Characteristics compared to Predicate Device
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To remove and destroy, by
exposure to UV radiation, bacteria and viruses in interior spaces. | To remove and destroy, by
exposure to UV radiation, bacteria and viruses in interior spaces. | To remove and destroy, by exposure to UV radiation, bacteria and viruses in interior spaces. | Identical |
| Indications for Use | Pūrgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo is non-sterile. | The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher. The Molekule Air Pro air purifier has been demonstrated to entrain and destroy the following bioaerosols under the following exposure/working conditions: | The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation.
The core technology components of the Molekule Air Pro RX air purifier have been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure conditions: | Similar
The indications for use of the devices are equivalent. The devices have different performance metrics for the chosen microorganisms. |
| | Pūrgo has been demonstrated to remove the following organisms under the following exposure conditions:
Avg. max log reduction / exposure time (min):
Methicillin resistant Staphylococcus epidermidis 4.6 (45) at normal speed
Bacillus globigii endospore 4.1 (60) at normal speed
Escherichia coli 5.4 (45) at normal speed
MS2 bacteriophage | Average Net Log Reduction / Time @ Fan
Speed 6. Room Temperature Test
Escherichia Coli $4.20 +/- 0.11 / 90 mins$
Bacillus Subtilis $4.02 +/- 0.23 / 30 mins$ | Average Maximum log reduction /exposure time (hours):
Room Temperature
Virus, MS2 bacteriophage $5.21 / 24 hours$ | |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194) | Molekule Air Pro RX
(K200500) | Comparison |
| | | Primary Predicate | Secondary Predicate | |
| | 5.4 (60) at normal speed
Phi-X174 bacteriophage
4.4 (45) at normal speed
Aspergillus brasiliensis spore
4.3 (90) at normal speed | Aspergillus Brasiliensis
$4.15 \pm 0.06$ / 60 mins
MS2 Bacteriophage
$4.38 \pm 0.15$ / 30 mins
Single Pass Mechanical
Filtration Efficiency
Particulate Matter 0.3 to 1.0
micron size particles 95% or
greater according to
ASHRAE 52.2 | | |
| User | Healthcare Professional
Lay User | Healthcare Professional
Lay User | Healthcare Professional | Identical |
| Environment of Use | Hospital and other healthcare
setting.
General Surgery Setting.
Home healthcare. | Hospital and other
healthcare setting.
Home healthcare. | Hospital and general
surgery setting | Similar
The Environment of Use of
the Pūrgo is identical to
that of the primary
predicate as both can be
used in a hospital and
other healthcare setting
and the home healthcare
environments.
The Environment of Use of
the Pūrgo is identical to
that of the secondary
predicate device as both
can be used in the hospital
and general surgery
setting. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Placement | Pūrgo will work in any room,
but giving it a space in a
central location is
recommended. Placement
near the patient is key.
Pūrgo may be used in
surgical suites.
Pūrgo is designed for rooms
up to 3000 ft³. | Air pro will work in any
room, but giving it a space
in a central location, is
recommended. Placement
near the patient is key.
It should not be used in
surgical suites or in rooms
with air separation devices.
It is designed for rooms
under 1000 ft². | Specific information on
placement not available
Device can be used in
surgical suites. | Similar
The Placement of Pūrgo is
equivalent to that of the
primary predicate in a
central location and that of
the secondary predicate
device in a surgical suite. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| User Control | Touch panel with selections
for 3 fan speeds, power
button, timer, and UV and
airflow indicators. | LCD screen with capacitive
touchscreen interface. User
Interface includes several
dedicated screens for fan
speed control, PM sensor
readings in addition to other
administrative functions.
Application controls mimic
device touch panel. | One knob controls the
four speed fan setting
One button turns the unit
on and off. | Similar
The User Controls of the
devices are equivalent, as
all provide a user interface
allowing the user control of
major functions of the
device.
The devices differ as the
primary predicate uses an
LCD screen with an
associated software
application and the
secondary predicate device
uses a knob and button
while Pūrgo has a static
interface on a touch panel.
This difference does not
affect the intended use or
safety and effectiveness of
the device. |
| Software | Basic Firmware; used to turn
the unit on, off, change fan
speed, and other
administrative functions
(timer, UV and airflow status). | Basic Firmware and App;
used to turn the unit on, off,
and change fan speed. | Basic Firmware; used to
turn the unit on, off, and
change fan speed. | Similar
All devices utilize firmware
which provides equivalent
functionality. The primary
predicate has an additional
software application in
addition to its device
firmware. This difference
does not affect the
intended use or safety and
effectiveness of the device. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Mechanism of
Action | Air is pulled through a multi-
layer filter (pre-filter, activated
carbon, HEPA) to remove
microorganisms and then into
a UV chamber (SteriDuct)
containing UV-C light with
sufficient energy to kill any
remaining microorganisms. | UV light of sufficient energy
(UV-A) activates
photocatalyst that destroys
microorganisms entrained
on the filter through a
photochemical reaction. | UV light of sufficient
energy (UV-A) activates
photocatalyst that
destroys microorganisms
entrained on the filter
through a photochemical
reaction. | Similar
The mechanisms of action
of the devices are similar
as all devices utilize
filtration and UV irradiation
to remove microorganisms
from air.
The devices differ as the
Pūrgo device first filters the
air and then separately
applies UV-C light to any
microorganisms which are
able to pass through the
filter while the predicates
use technology which first
captures microorganisms
on a catalytic filter and
applies UV-A light to the
filter to destroy
microorganisms via a
photochemical reaction.
This difference does not
affect the intended use of
the device and safety and
effectiveness has been
confirmed via performance
testing. |
| Installation | Free standing | Free standing | Free standing | Identical |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Filter | Pūrgo Filter:
Multi-layer filter with 1/8" thick pre-filter, 1/8" thick activated carbon filter, and HEPA filter media Dimensions: 16.5" x 19.5" x 2.5" HEPA filter: Number of pleats: 140 Depth of pleats: 42mm Minimum filter media area: 61 sq ft | Catalytic Filter:
Proprietary multi-layer filter media Dimensions: 6.18 in (diameter), 6.55 in Height. Pleats per inch: 3 pleats per inch of outer circumference Total Filter surface area: 616 in2 Filter coated with proprietary photocatalyst and a metal wire mesh MERV16 | Pre-Filter:
Synthetic Media for mechanical filtration upstream of the PECO filter Dimensions 20 in x 20 in x 4 in Pleats per inch 1.5 Total Filter surface area 4800 sq. in. Catalytic Filter: Proprietary filter media Dimensions 20 in x 20 in x 4 in Pleats per inch 1.5 Total Filter surface area 4800 sq in Filter coated with the proprietary photocatalyst and a wire-mesh | Similar
All devices utilize multi-layer filter(s). The devices differ as the Pūrgo filter utilizes HEPA and activated carbon filtration while the primary and secondary predicate devices utilize a proprietary multi-layer catalytic PECO filter. This difference does not affect the intended use of the device and safety and effectiveness has been confirmed via performance testing. |
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| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
|---------------|--------------------------------------|----------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photocatalyst | None | Proprietary catalyst | Proprietary catalyst | Different
Pūrgo does not use a
photocatalyst as its
mechanism of action is
achieved via filtration and
UV-C irradiation, unlike the
predicate devices which
rely on a photo-catalytic
reaction for microorganism
destruction. This difference
does not affect the
intended use of the device
and safety and
effectiveness has been
confirmed via performance
testing. |
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| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Light Source | UV Type: UV-C UV Light Source: LED Wavelength: 265 nm Total of 4 UV LEDs Total UV Power: 110 mW SteriDuct Irradiance
(Minimum): 0.24 mW/cm² | UV Type: UV-A UV Light Source: LED Wavelength: 320-400 nm Total of 20 UV LEDs Total UV Power: 16 W Filter Irradiance
(Minimum): 20 W/m² | UV Type: UV-A UV Light Source: LED Wavelength: 320-400 nm Power per Lamp / String: 11.4W Number of Lamps / String: 6 Total UV Power: 68.4W Filter Irradiance
(Minimum): 30 W/m² | Similar
All devices utilize a UV light source for the purpose of destroying microorganisms.
The Pūrgo differs from the predicates as the Pūrgo device uses UV-C light at 265 nm in order to destroy microorganisms while the primary and secondary predicate devices use UV-A light at 320 to 400 nm to destroy microorganisms.
This difference does not affect the intended use of the device and safety and effectiveness has been confirmed via performance testing. |
| Air Source | Centrifugal Fan | Centrifugal Fan | Centrifugal Fan | Identical |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Flow Control | Three speeds (sleep, normal,
boost) provide minimum 125-
315 CFM flow. | 6 speeds (low-high)
Provide 25-260 CFM | Four speeds (low,
medium, high, boost)
provide 300 - 800 CFM
flow. | Similar
All devices allow for the
user to control flow by
providing an adjustable
speed setting. The Pūrgo
airflow range reaches a
max of 315 CFM compared
to the primary predicate's
max of 260 CFM. This
difference does not affect
the intended use of the
device and safety and
effectiveness has been
confirmed via performance
testing. |
| Device Air Changes
Per Hour (ACH) | 1.875 – 2.36 device air
changes per hour on Boost,
250 - 315 CFM, in a 1000 ft²
room. | 1.83 device air changes per
hour on setting 6, roughly
260 CFM, in a 1000 ft² room | 6-9 ACH when used in
room with volume of
4000 cubic feet
(a typical Operating
Room Volume) with
flowrates of 450-650
CFM at settings 2 and 3. | Similar
Both Pūrgo and the primary
predicate achieve around
1.8 ACH on the maximum
speed setting. Pūrgo
achieves slightly higher
ACH during optimal
performance. This
difference does not affect
the intended use of the
device and safety and
effectiveness has been
confirmed via performance
testing. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Particulate Sensor | None | Optical Particle Sensor | None | Similar to Secondary
Predicate
Neither Pūrgo nor the
secondary predicate device
utilize a particulate sensor
that the primary predicate
has. This difference does
not affect the intended use
of the device or safety and
effectiveness. |
| Fan Exposure
Safety Features | Diffuser panel on side of
device and SteriDuct cover
behind filter door to block
user from accessing spinning
fan without tools. Safety
feature confirmed by UL 507. | Vanes at outlet and
Honeycomb inlet of fan with
small enough grating to
block user from accessing
spinning fan without tools.
Safety feature confirmed by
UL 507. | Grill at outlet and inlet of
fan with small enough
grating to block user from
accessing spinning fan
without tools. Safety
feature confirmed by
UL507. | Similar
All devices provide
protection from the
spinning fan for users. The
safety features have been
confirmed with UL 507
testing. |
| UV Light Exposure
Safety Features | Safety interlock switch exists
in filter door to ensure if the
door is open or if a filter is
missing, the unit will not
operate. The purpose of
these switches is to protect
the user from any possibility
of exposure to direct contact
with UV light. Safety feature
confirmed by UL 507. | If a validated, serialized,
Molekule filter is missing,
the unit will not operate. The
unit authenticates the filter
via NFC, before and during
operation.
The purpose of this system
is to protect the user from
any possibility of exposure
to direct contact with UV-A
light that would occur
without a genuine Molekule
Filter being present. | Safety switches exist in
the following locations:
PECO filter door, pre
filter door, PECO filter
compartment, and pre
filter compartment. If any
door is open or if a filter
is missing, the unit will
not operate. The purpose
of these switches is to
protect the user from any
possibility of exposure to
direct contact with UV
light. Safety feature
confirmed by UL507. | Similar
All devices provide
protection from the
exposure to UV light. The
safety features have been
confirmed with UL 507
testing. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Input Voltage | 120 Volt | 120 Volt | 120 Volt
(plugs into standard
single phase 120 Volt
outlet) | Identical |
| Current | Up to 1.00 Amps | Up to 1.27 Amps | Up to 3.72 amps | Different
The Pūrgo and predicates
differ due to the technical
specifications of the
devices (i.e. the Pūrgo
uses fewer LEDs, fan
power consumption may
differ) which results in
lower power and current
consumption. This
difference does not affect
the intended use or safety
and effectiveness of the
device. |
| Power Consumption | Up to 120 Watts | Up to 152.8 Watts…
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K213753](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K213753)
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