Data / Medical devices / Ventilatory Effort Recorder / United States
FDA-registered makers of Ventilatory Effort Recorder in the United States: 35 establishments
35 establishments in the United States are registered with the FDA to make Ventilatory Effort Recorder (product code MNR). 22 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Ventilatory Effort Recorder
- Product code
- MNR
- Country
- United States
Makers of Ventilatory Effort Recorder in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 8 | June 26, 2009 | 0 | 1 | 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 |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 4 | June 26, 2009 | 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 |
| Snap Diagnostics, L.L.C. | Vernon Hills, IL, United States | Manufacturer | 3 | June 4, 2024 | 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 |
| Resmed Corp | San Diego, CA, United States | Complaint file establishment, Manufacturer | 2 | February 24, 2022 | 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 |
| 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 |
| 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 |
| Brainmatterz, Inc | McKinney, TX, United States | 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 | |
| East West Wisconsin | Whitewater, WI, United States | 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 | |
| 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 | |
| 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 | |
| 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 | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.