FloPatch FP120
Device Facts
| Record ID | K252810 |
|---|---|
| Device Name | FloPatch FP120 |
| Applicant | Flosonics Medical |
| Product Code | DPW · Cardiovascular |
| Decision Date | Apr 24, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.2100 |
| Device Class | Class 2 |
Indications for Use
The FloPatch FP120 is a wireless, non-invasive Doppler ultrasound system indicated to aid medical professionals as an adjunctive assessment in performing Critical Care Ultrasonography (CCUS) for Targeted Volume Management (TVM). The FloPatch FP120 is indicated for use for the non-invasive assessment of blood flow in peripheral vasculature (including the carotid) in a target vessel. The device operates in a single mode, Continuous Wave (CW), providing quantitative flow metrics for arterial flow. The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.
Device Story
Wireless, non-invasive Doppler ultrasound system; consists of signal processing unit and adhesive strap. Transmits ultrasonic waves to peripheral vessels; receives reflected Doppler-shifted signals from moving blood cells. Wireless transmission to mobile medical application for processing. Displays Max Velocity trace, Max VTI, and Corrected Flow Time. Used by physicians/nurses in hospitals/clinics for Targeted Volume Management. Provides quantitative arterial flow metrics to assist clinical decision-making regarding patient volume status.
Clinical Evidence
Bench testing only. Performance data validated measurement of forward and reverse blood flow velocities in the 10–170 cm/s range. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993 series confirmed.
Technological Characteristics
Wireless, single-use, body-worn Doppler ultrasound. 4 MHz center frequency. Continuous Wave (CW) mode. LiPo battery powered. IP67 ingress protection. Type BF defibrillation-protected. Materials biocompatible per ISO 10993-1, -5, -10, -12, -21. Dimensions: 54x35x14 mm (device only). Connectivity: Wireless to mobile medical application.
Indications for Use
Indicated for adult patients (18+ years) requiring non-invasive assessment of blood flow in peripheral vasculature, including the carotid artery, as an adjunctive tool for Critical Care Ultrasonography (CCUS) and Targeted Volume Management (TVM).
Regulatory Classification
Identification
A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.
Predicate Devices
- FloPatch FP120 (K251114)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 24, 2026
Flosonics Medical
Caleb Chin
Sr. Director of Operations
325 Front St. W, Floor 4
Toronto, ON M5V2Y1
Canada
Re: K252810
Trade/Device Name: FloPatch FP120
Regulation Number: 21 CFR 870.2100
Regulation Name: Cardiovascular Blood Flowmeter
Regulatory Class: Class II
Product Code: DPW
Dated: September 3, 2025
Received: March 13, 2026
Dear Caleb Chin:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252810 - Caleb Chin
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K252810 - Caleb Chin
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Sincerely,
**STEPHEN C. BROWNING -S**
LCDR Stephen Browning
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252810 | |
| Device Name FloPatch FP120 | |
| Indications for Use (Describe) The FloPatch FP120 is a wireless, non-invasive Doppler ultrasound system indicated to aid medical professionals as an adjunctive assessment in performing Critical Care Ultrasonography (CCUS) for Targeted Volume Management (TVM). The FloPatch FP120 is indicated for use for the non-invasive assessment of blood flow in peripheral vasculature (including the carotid) in a target vessel. The device operates in a single mode, Continuous Wave (CW), providing quantitative flow metrics for arterial flow. The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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FloPatch FP120
FLOSONICS MEDICAL
# 510(k) Summary
1. Submitter Information
| Submitter: | Flosonics Medical |
| --- | --- |
| Address: | 325 Front St W, Floor 4
Toronto, ON
Canada M5V 2Y1 |
| Telephone: | 1-289-998-2982 |
| Contact: | Caleb Chin |
| Date Prepared: | August 25, 2025 |
2. Device Information
| Trade Name: | FloPatch FP120 |
| --- | --- |
| Common Name: | Cardiovascular Blood Flowmeter |
| Classification: | Class II per CFR 870.2100 |
| Classification Name: | Cardiovascular blood flowmeter |
| Product Code: | DPW |
3. Purpose of Submission
The purpose of this submission is to modify the device's indications for use.
4. Predicate Device Information
| 510(k) No. | Device | Manufacturer |
| --- | --- | --- |
| Primary: K251114 | FloPatch FP120 | Flosonics Medical |
5. Device Description
The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic transducer to a peripheral vessel. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.
K252810
CONFIDENTIAL
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FloPatch FP120
FLOSONICS
# 6. Intended Use
The FloPatch FP120 is a wireless, non-invasive Doppler ultrasound system indicated to aid medical professionals as an adjunctive assessment in performing Critical Care Ultrasonography (CCUS) for Targeted Volume Management (TVM).
The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature (including the carotid) in a target vessel. The device operates in a single mode, Continuous Wave (CW), providing quantitative flow metrics for arterial flow.
The device is intended to be used by medical professionals, such as physicians and nurses, in hospital and professional environments. The device is intended for prescription use on adults only.
# 7. Comparison to Predicate Devices
| Feature/Characteristic | FloPatch (FP120)Subject Device [K252810] | FloPatch (FP120)Primary Predicate [K251114] |
| --- | --- | --- |
| Class/Classification/Product Code | Class II/DPW(21 CFR 870.2100 Cardiovascular blood flowmeter) | Same |
| Intended Use | The FloPatch FP120 is a wireless, non-invasive Doppler ultrasound system indicated to aid medical professionals as an adjunctive assessment in performing Critical Care Ultrasonography (CCUS) for Targeted Volume Management (TVM).The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature (including the carotid) in a target vessel. The device operates in a single mode, Continuous Wave (CW), providing quantitative flow metrics for arterial flow.The device is intended to be used by medical professionals, such as physicians and nurses, in hospital and professional environments. The device is intended for prescription use on adults only. | The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only.The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only. |
K252810
CONFIDENTIAL
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FloPatch FP120
FLOSONICS
MEDICAL
| Indications for Use | Identical to Intended Use | Same |
| --- | --- | --- |
| Intended Users | Medical professionals such as Physicians and Nurses | Same |
| Use environment | Hospitals. professional environments such as clinics and doctor’s offices. | Same |
| Patient Population | Adults, ages 18 years and older | Same |
| Intended for Prescription Use | Yes | Same |
| Installation and Use | Body Worn | Same |
| Theory of Operation | Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature. | Same |
| Center Frequency | 4 MHz | Same |
| Global Maximum Outputs/Worst Case Setting | Max ISPTA.3 (mW/cm2) – 53.58
Max MI – 3.09E-02 | Same |
| Modes of Operation | One mode, continuous | Same |
| Reusable | No, the device is single use for a single patient. | Same |
| Dimensions | With adhesive
Height 145 mm
Width 76 mm
Depth 32 mm
Without Adhesive
Height 54 mm
Width 35 mm
Depth 14 mm | Same |
| Weight | 21 gms | Same |
K252810
CONFIDENTIAL
Page 3 of 5
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FloPatch FP120
FLOSONICS
MEDICAL
| The degree of protection against harmful ingress of liquid | IP67 | Same |
| --- | --- | --- |
| Type of Power Source | LiPo Battery (IEC 62133 certified) | Same |
| Battery Operating Voltage | 4.2 V for the battery | Same |
| Battery Chemistry | Lithium Polymer | Same |
| The degree of protection against electric shock | Type BF (Defibrillation Protected) | Same |
| Buttons | One Power Button on FloPatch FP120 hardware | Same |
| Status LED | One, power and battery Indicator | Same |
| Onboard Screen | None - Multi Touch Mobile Medical Application screen | Same |
| Displays Doppler Waveform | Yes | Same |
| Displays Max Velocity Waveform | Yes | Same |
| Displays VTI Calculation | Yes | Same |
| Displays Corrected Flow Time Calculation | Yes | Same |
| Displays Peak Systolic Velocity | Yes | Same |
| Wireless Mobile Application | Yes | Same |
| Calibration Required | No | Same |
| Maintenance | Single-use device | Same |
| Contact Classification | Surface Device, Intact Skin Contacting, Contact Duration: <24 hrs | Same |
K252810
CONFIDENTIAL
Page 4 of 5
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FloPatch FP120
FLOSONICS
MEDICAL
| Electrical Safety | IEC 60601-1:2005+A1:2012+A2:2020 | Same |
| --- | --- | --- |
| EMC | IEC 60601-1-2:2014+A1:2020 | Same |
| Ultrasound Basic Safety and Essential Performance | IEC 60601-2-37:2015 | Same |
| Biocompatibility | ISO 10993-1, -5, -10, -12, -21 | Same |
| Range of Validated Flow Velocities | 10 – 170 cm/s | Same |
## 8. Performance Data
Performance data demonstrates that the FloPatch FP120 can measure both forward and reverse blood flow velocities in a target vessel from 10 - 170 cm/s.
## 9. Conclusion
From the information provided, the FloPatch FP120 has been shown to be substantially equivalent to the legally marketed predicate device identified in this submission and does not present any changes to safety or effectiveness.
K252810
CONFIDENTIAL
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