RP Check (RP01)
Device Facts
| Record ID | K260671 |
|---|---|
| Device Name | RP Check (RP01) |
| Applicant | MD Diagnostics, Ltd. |
| Product Code | CAP · Anesthesiology |
| Decision Date | Oct 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2600 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The RP Check is intended to measure both inspiratory (MIP) and expiratory (MEP) mouth pressures and Sniff nasal pressures (SNIP) generated by a patient after being trained in the technique by a qualified healthcare professional. The RP Check is suitable for both adult and paediatric patients from 6 years and older, there is no upper age limit providing the patient can comply and perform the test as instructed. Interpretation of the values obtained should only be performed by an appropriate healthcare professional.
Device Story
Handheld, battery-operated respiratory pressure monitor; measures maximum inspiratory (MIP), maximum expiratory (MEP), and sniff nasal inspiratory pressures (SNIP). Uses piezo pressure transducer to convert airway pressure into digital signals; microprocessor calculates peak pressure (Ppeak), maximum rate of pressure development (MRPD), and maximum relaxation rate (MRR). Used in healthcare environments by clinicians to assess respiratory muscle strength. Patient performs maneuvers via single-use system with filter; results displayed on backlit LCD. Output aids clinical assessment of respiratory function; helps monitor muscle strength in patients with respiratory conditions.
Clinical Evidence
No clinical or animal data included. Substantial equivalence established via bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), firmware verification, and biocompatibility (ISO 10993-1, ISO 18562-1/2/3/4).
Technological Characteristics
Handheld, battery-operated (9V PP3). Piezo pressure transducer sensing. Range ±300 cmH2O; resolution 1 cmH2O. Graphic LCD (128x128). Single-patient use breathing circuit with filter. Complies with IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, and ISO 10993-1.
Indications for Use
Indicated for adult and paediatric patients aged 6 years and older requiring respiratory mouth (MIP/MEP) and/or nasal (SNIP) pressure measurement. Contraindicated in patients with aneurysms, uncontrolled hypertension, or urinary incontinence.
Regulatory Classification
Identification
An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.
Predicate Devices
- MicroMPM (K940375)
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
October 26, 2026
MD Diagnostics, Ltd.
Daniel Quirke
Director
Slip 7 Annexe The Historic Dockyard
Chatham, Kent ME4 4TZ
United Kingdom
Re: K260671
Trade/Device Name: RP Check (RP01)
Regulation Number: 21 CFR 868.2600
Regulation Name: Airway Pressure Monitor
Regulatory Class: Class II
Product Code: CAP
Dated: September 25, 2026
Received: September 25, 2026
Dear Daniel Quirke:
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.
Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260671 - Daniel Quirke
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When to Submit a 510(k) for a Change to an Existing Device" (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 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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-
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K260671 - Daniel Quirke
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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).
Sincerely,
# ETHAN L. NYBERG -S
Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K260671
Device Name
RP Check (RP01)
Indications for Use (Describe)
The RP Check is intended to measure both inspiratory (MIP) and expiratory (MEP) mouth pressures and Sniff nasal pressures (SNIP) generated by a patient after being trained in the technique by a qualified healthcare professional. The RP Check is suitable for both adult and paediatric patients from 6 years and older, there is no upper age limit providing the patient can comply and perform the test as instructed. Interpretation of the values obtained should only be performed by an appropriate healthcare professional.
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.**
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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RP Check - 510(k) Summary
510(k) Ref: K260671
# 510(k) Summary
## Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
| Submitter's Identification: | |
| --- | --- |
| Applicant: | MD Diagnostics Ltd |
| Address: | Slip 7 Annexe The Historic Dockyard Chatham Kent, GB ME4 4TZ |
| Registered Establishment Number: | 3009896423 |
| Owner/Operator Number: | 10045293 |
| Phone: | +44 (0)1634 949010 |
| Contact: | Daniel Quirke Director |
| Email: | daniel@mdd.org.uk |
| Date of Summary | 16-Oct-2026 |
## Device Information:
Below summarises the Device Classification information regarding the RP Check.
| Device Proprietary Name | RP Check |
| --- | --- |
| Common Name: | Respiratory Pressure Monitor |
| Trade Name: | RP Check |
| Model | RP01 |
| Product Code(s): | CAP |
## Identified Product Code
| Device Information: | |
| --- | --- |
| Regulation Description | Airway pressure monitor. |
| Code of Federal Regulation: | 21 CFR 868.2600 |
| Identification | An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Product Code: | CAP |
| Product Class: | II (performance standard) |
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Rev 3
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RP Check - 510(k) Summary
510(k) Ref: K260671
MD
MANAGEMENTS LTD.
| Type of Submission: | 510(k) |
| --- | --- |
Identified Predicate
| Substantial Equivalence: | | | |
| --- | --- | --- | --- |
| Manufacturer | Trade Name | Regulation & Product Code | 510(k) Number |
| Micro Direct Inc | MicroMPM | 21 CFR 868.2600 | K940375 |
### Submission Description
This Traditional 510(k) presents a new medical device for the measurement of respiratory pressure. Well-established methods have been used to evaluate the change and the data to be reviewed is provided in a summary in this submission.
### Device Description
The RP Check is a handheld, portable, battery-operated device used for rapid assessment of respiratory muscle strength. The unit can measure mouth pressures - maximum inspiratory (MIP); maximum expiratory (MEP) pressures and sniff nasal inspiratory pressure (SNIP). The unit measures the pressures generated in cmH2O, and these are displayed on the backlit display. The unit is controlled by a microprocessor and pressure measurements are measured using a piezo pressure transducer.
The RP Check provides the following measurements:
- Mouth pressures:
○ Maximum expiratory pressure (MEP) – the highest average expiratory pressure achieved over one second
○ Maximum inspiratory pressure (MIP) – the highest average inspiratory pressure achieved over one second
- Peak pressure (Ppeak) – the maximum pressure achieved during the test
○ Maximum Rate of Pressure Development (MRPD) – the highest rate of change of pressure on the upward stroke (before the one second average is achieved) of either a MIP or MEP test
○ Maximum Relaxation Rate (MRR) – the maximum rate of change of pressure on the downward stroke (after the one second average) of either a MIP or MEP test, divided by the one second sustainable pressure value (the MIP or MEP value respectively)
- Nasal pressure:
- Sniff nasal inspiratory pressure (SNIP) – the peak pressure obtained from a maximum sniff nasal manoeuvre
### Intended/Indications for Use
The RP Check is intended to measure both inspiratory (MIP) and expiratory (MEP) mouth pressures and Sniff nasal pressures (SNIP) generated by a patient after being trained in the technique by a qualified healthcare professional. The RP Check is suitable for both adult and paediatric patients from 6 years and older, there is no upper age limit providing the patient can comply and perform the test as instructed. Interpretation of the values obtained should only be performed by an appropriate healthcare professional.
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Rev 3
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RP Check - 510(k) Summary
510(k) Ref: K260671
## Substantial Equivalence
The candidate device is substantially equivalent to the predicate, K940375, the MicroMPM and a comparison of the key characteristics is summarised in Table 1.
| Characteristic | Subject Device | Predicate Device MicroMPM K940375 | Equivalence Comparison |
| --- | --- | --- | --- |
| Intended Use | The RP Check is intended to measure both inspiratory (MIP) and expiratory (MEP) mouth pressures and Sniff nasal pressures (SNIP) generated by a patient after being trained in the technique by a qualified healthcare professional. The RP Check is suitable for both adult and paediatric patients from 6 years and older, there is no upper age limit providing the patient can comply and perform the test as instructed. Interpretation of the values obtained should only be performed by an appropriate healthcare professional. | The MicroRPM (Respiratory Pressure Meter) is a handheld diagnostic instrument designed for rapid assessment of inspiratory and expiratory muscle strength. The unit can measure the maximum inspiratory and expiratory mouth pressures, MIP and MEP, and the Sniff Nasal Inspiratory Pressure, SNIP. The system is intended for use with adults and pediatric patients over the age of 3 years in hospitals, physician offices, laboratories and occupational health testing environments. | Equivalent |
| Rx vs OTC | Rx | Rx | Equivalent / Same |
| Contraindications | Mouth or nasal pressure testing should be avoided in patients with: Aneurisms Uncontrolled hypertension Urinary incontinence | Pathological conditions resulting in relatively large pressure swings in the abdomen or thorax. Aneurisms Uncontrolled hypertension Urinary incontinence | Equivalent |
| Patient Population | Patients over 6 who require a respiratory mouth and/or nasal pressure measurement | Patients over 3 who require a respiratory mouth and/or nasal pressure measurement | Equivalent – the subject device is for use in over 6 years old; whereas the predicate is 3 and over. |
| Use Environment | Healthcare environment | Healthcare environment | Equivalent / Same |
| Measurement Method | Pressure sensor | Pressure sensor | Equivalent / Same |
| Measurements | Maximum Expiratory Pressure (MEP) Maximum Inspiratory Pressure (MIP) Sniff Nasal Inspiratory Pressure (SNIP) | Maximum Expiratory Pressure (MEP) Maximum Inspiratory Pressure (MIP) Sniff Nasal Inspiratory Pressure (SNIP) | Equivalent / Same |
| Additional derived measurements | Maximum Rate of Pressure Development (MRPD) Maximum Rate of Relaxation (MRR) Ppeak (maximum pressure | Maximum Rate of Pressure Development (MRPD) Maximum Rate of Relaxation (MRR) | Substantially Equivalent – both devices can show derived measures, however the RP Check performs this on screen |
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Rev 3
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RP Check - 510(k) Summary
510(k) Ref: K260671
MD
MANAGEMENTS LTD.
| Characteristic | Subject Device | Predicate Device MicroMPM K940375 | Equivalence Comparison |
| --- | --- | --- | --- |
| | | | not on connected software |
| Operating Pressure | ± 300 cmH2O | ± 300 cmH2O | Equivalent / Same |
| Burst Pressure | ± 2000 cmH2O | ± 700 cmH2O | Substantially equivalent – the subject device has a higher burst pressure for safety. |
| Resolution | 1 cmH2O | 1 cmH2O | Equivalent / Same |
| Accuracy | +/-5% | +/-3% | Substantially equivalent – the small difference in accuracy specification (±5% vs ±3%) is not clinically significant and does not introduce new or increased risks (see rationale). |
| Operating Temperature | 10-30°C | 32 – 104°F (*0-40°C)* | Substantially Equivalent |
| Operating Pressure | Atmospheric 10% | Unknown | Substantially Equivalent |
| Operating humidity | 30% to 90% RH | 30% to 90% RH | Equivalent / Same |
| Storage & Transport Temperature | -20 to + 70°C | -4 – 158°F (-20 to +70°C)* | Equivalent / Same |
| Storage & Transport Humidity | 10% to 90% RH | 10% to 90% RH | Equivalent / Same |
| Patient sample system | Single patient use inspiratory, expiratory and nasal system with filter | Single patient use inspiratory, expiratory and nasal system with filter | Equivalent / Same |
| Display | 128 X 128 Pixels Graphic LCD | Alphanumeric display | Substantially Equivalent |
| Power Supply | Single 9v PP3 battery | Single 9v PP3 battery | Equivalent / Same |
| Weight (approximate) | 160g including battery | ~6ounces (170g) | Equivalent / Same |
| Dimensions | 135mm x 65mm x 30mm | ~6.5" x 2.5" x 1" (165 x 6.4 x 2.5cm)* | Equivalent / Same |
Table 1: Comparison of Characteristics between the RP Check and the predicate
### Technological Characteristics
The subject device and the predicate device both measure respiratory pressure and have substantially equivalent indications for use, operating principles, performance, and technical specification. The measurement types, range, resolution and accuracy are identical, and the respiratory pressure measurement test method are performed by the patient in the same way.
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Rev 3
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RP Check - 510(k) Summary
510(k) Ref: K260671
MD
MANAGEMENTS LTD.
## Summary of Non-Clinical Tests (Performance data)
The performance of the RP Check is identical to the predicate device in terms of technical specification and safety. There are no significant differences.
Verification and validation activities established the safety and performance of the RP Check based on the following tests, which were all passed:
**Electrical Safety:** The RP Check was tested to confirm that it met the applicable standards for electrical safety (IEC 60601-1).
**Electromagnetic compatibility:** The RP Check was tested to confirm it meets the applicable standards for electromagnetic compatibility (EMC) (IEC 60601-1-2).
**Device verification:** The device verification and validation testing was performed to verify the firmware of the RP Check and measurement accuracy.
**Software & Risk Management:** The subject device used the same FDA Guidance and International Standards for software development process (IEC 62304) software documentation (Content of Premarket Submissions for Device Software Functions), Risk Management process (IEC 14971), cybersecurity (Content of Premarket Submissions for Management of Cybersecurity in Medical Devices).
**Biocompatibility:** Analysis of the RP Check has demonstrated compliance to ISO 10993-1: Biological evaluation of medical devices – Guidance and ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process, including Parts -2, -3 & -4.
**Device Ship/Transport Testing:** Ensure device, enclosed in the selected shipping packaging, meets specifications.
## Summary of Animal & Clinical Studies
Substantial equivalence is based on an assessment of non-clinical performance data, and no animal or clinical performance data is included.
## Conclusion
Based on the information presented above and supported by the performance data, along with the risk assessment and information provided in the device labelling, the RP Check device is substantially equivalent to the predicate device (MicroMPM) in in terms of safety, performance, functionality and indications for use and is as safe and effective for its intended use.
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