Data / Medical devices / Ventilatory Effort Recorder
Ventilatory Effort Recorder (MNR): 73 FDA-registered makers in 18 countries
73 establishments in 18 countries are registered with the FDA to make Ventilatory Effort Recorder (product code MNR, Class 2, 21 CFR 868.2375). 41 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 165 510(k) clearances under this code, the latest on September 24, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MNR
- Device class
- 2
- Regulation
- 868.2375
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 35 |
| Israel | 7 |
| United Kingdom | 5 |
| Singapore | 4 |
| Germany | 3 |
| China | 3 |
| Australia | 2 |
| Canada | 2 |
| Mexico | 2 |
| India | 2 |
| Netherlands | 1 |
| Iceland | 1 |
| Hong Kong | 1 |
| France | 1 |
| Italy | 1 |
| Taiwan | 1 |
| Estonia | 1 |
| Malaysia | 1 |
Makers of Ventilatory Effort Recorder
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Itamar Medical | CAESAREA Haifa, Israel | Manufacturer | 9 | September 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Itamar Medical Ltd. (Alon) | Caesarea Haifa, Israel | Manufacturer | 9 | September 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 8 | June 26, 2009 | 0 | 1 | 0 | api.fda.gov |
| Compumedics Limited | Melbourne Victoria, Australia | Complaint file establishment, Manufacturer | 4 | August 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Huxley Medical | Atlanta, GA, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 4 | December 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek) | OAKVILLE Ontario, Canada | Complaint file establishment, Manufacturer, Specification developer | 4 | September 27, 2019 | 0 | 1 | 0 | api.fda.gov |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 4 | June 26, 2009 | 0 | 0 | 0 | api.fda.gov |
| Somnomedics AG | RANDERSACKER Bavaria, Germany | Manufacturer | 4 | January 30, 2015 | 0 | 0 | 0 | api.fda.gov |
| WATERMARK MEDICAL Inc | Atlanta, GA, United States | Specification developer | 4 | April 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Neurovirtual Usa, Inc. | Fort Lauderdale, FL, United States | Manufacturer | 3 | December 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Onera B.V. | Eindhoven Noord-Brabant, Netherlands | Manufacturer | 3 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Snap Diagnostics, L.L.C. | Vernon Hills, IL, United States | Manufacturer | 3 | June 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Acurable Limited | London, United Kingdom | Exporter to the US, Specification developer | 2 | February 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Braebon Medical Corp. | KANATA Ontario, Canada | Manufacturer | 2 | September 6, 2006 | 0 | 0 | 0 | api.fda.gov |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer | 2 | December 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dymedix Diagnostics Inc | Shoreview, MN, United States | Specification developer | 2 | May 5, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ensodata, Inc. | Madison, WI, United States | Manufacturer | 2 | February 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 2 | February 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Nox Medical | Reykjavik, Iceland | Manufacturer, Specification developer | 2 | November 6, 2015 | 0 | 1 | 0 | api.fda.gov |
| Resmed Corp | San Diego, CA, United States | Complaint file establishment, Manufacturer | 2 | February 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Resmed Pty Ltd. | BELLA VISTA New South Wales, Australia | Manufacturer | 2 | April 30, 2015 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Contract manufacturer, Manufacturer | 2 | April 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Wesper Inc. Lic | Long Island City, NY, United States | Manufacturer | 2 | March 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Advanced Brain Monitoring, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | March 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Apneicare, LLC | Columbus, OH, United States | Manufacturer, Specification developer | 1 | January 2, 2009 | 0 | 0 | 0 | api.fda.gov |
| Belun Technology Company Limited | New Territories, Hong Kong | Manufacturer | 1 | February 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cnsac Medshop GMBH | Theilheim Bavaria, Germany | Specification developer | 1 | September 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Dormotech Medical Ltd. | Afula Northern, Israel | Specification developer | 1 | January 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Happy Health | Austin, TX, United States | Complaint file establishment, Manufacturer | 1 | June 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Huneo, LLC | Willoughby Hills, OH, United States | Manufacturer, Specification developer | 1 | July 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | December 6, 2000 | 0 | 0 | 0 | api.fda.gov |
| Mycardio | Denver, CO, United States | Manufacturer | 1 | August 14, 2019 | 0 | 0 | 0 | api.fda.gov |
| Mallinckrodt Manufacturing LLC | Madison, WI, United States | Manufacturer, Remanufacturer | 1 | June 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| Pranaq Pte. Ltd. | Singapore Central Singapore, Singapore | Manufacturer, Specification developer | 1 | February 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| ResMed Asia Pte. Ltd. | Singapore South West, Singapore | Contract manufacturer, Manufacturer | 1 | February 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| S.L.P. Ltd. | Tel-Aviv Tel Aviv, Israel | Manufacturer | 1 | October 6, 2004 | 0 | 0 | 0 | api.fda.gov |
| Sibel Health Inc. | Chicago, IL, United States | Manufacturer | 1 | July 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Specification developer | 1 | April 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | April 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| VivaQuant, Inc | Arden Hills, MN, United States | Manufacturer | 1 | June 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Withings | Issy-les-Moulineaux Ile-de-France, France | Complaint file establishment, Specification developer | 1 | September 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| B.Y. Medimor Ltd | Tiberias Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brainmatterz, Inc | McKinney, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogent Technology Limited | Felixstowe Suffolk, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Research, Inc. | Euclid, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convergent Dental | Waltham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ducommun LaBarge Technologies | Appleton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eb Neuro, S.P.A. | FLORENCE Tuscany, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| East West Wisconsin | Whitewater, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GVS Filter Technology UK Ltd | Lancaster Lancashire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ixensor Co Ltd | Taipei, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innokas Medical Estonia Ou | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions Jasper, Inc. | Jasper, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mehow Innovative (huizhou) Ltd. | Huizhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meiban Micro Pte Ltd | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirac, LLC | Lynchburg, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurotronics, LLC | Alachua, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oridion Medical 1987 Ltd. | Jerusalem, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P1 Technologies, Inc. | Cave Spring, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pepin MFG., Inc. | Lake City, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips India Limited - Sleep & Respiratory Care Business Unit | Bengaluru Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remote Diagnostic Technologies Ltd. | FARNBOROUGH Hampshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| REMware | Tampa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed Corp | Lithia Spgs, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed Malaysia Operations Sdn Bhd | Senai Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina- Sci Israel Medical Systems Ltd. | Maalot-Tarshiha Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skanray Technologies Limited | Mysore Karnataka, India | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Ltd. | HERTFORD Hertfordshire, United Kingdom | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Sanbor Medical Xiamen, Inc. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina-SCI Systems Singapore Pte. Ltd. | SINGAPORE North East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed de Mexico, S.A de C.V | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.