Is this your brand? Sign in to claim ownership.
Sign in to claim this brandRespironics Novametrix, LLC
United States·US-MF-000007951
Last updated September 17, 2026
What Respironics Novametrix, LLC makes
Respironics Novametrix, LLC manufactures home continuous positive airway pressure (CPAP) units, including pre-hospital and adjustable pressure models, as well as disposable PEEP valves and nasal oxygen cannulas with carbon dioxide sampling capabilities. The company also produces electrical monitoring spirometers, pulmonary function testing accessories like mouthpieces and filters, and patient monitoring systems for carbon dioxide levels, including sidestream modules and cuvettes. Breathing circuit gas-sampling sets and standalone CO₂ monitoring devices are part of its portfolio.
The company’s devices are classified under FDA regulations as Class I, Class II, Class IIa, and Class IIb, with listings in the FDA’s 510(k) and UDI databases, as well as the EU’s eudamed registry. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 3000, Minuteman Road, Andover, United States
- Website
- n/a
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Brenda Niel
- EUDAMED SRN
- US-MF-000007951
- FDA FEI Number
- 1219324
- DUNS Number
- —
Catalogue (174)
Page 4 of 4Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Respironics Novametrix, LLC has six FDA recall records initiated between September 2, 2002, and July 29, 2011, all of which are marked as terminated. The recalls involve issues with audible alarms failing to activate under specific alert conditions, pressure lines potentially becoming occluded and displaying incorrect tidal volumes, and software errors causing two respiratory parameters (MValv and Vt/kg) to be inaccurately represented as higher than actual.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 29, 2011 | Z-3288-2011 | — | terminated | Pressure lines maybe occluded and display incorrect tidal volumes. |
| Jul 29, 2011 | Z-3287-2011 | — | terminated | Pressure lines maybe occluded and display incorrect tidal volumes. |
| Jan 4, 2011 | Z-2168-2011 | — | terminated | Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual. |
| Jan 4, 2011 | Z-2167-2011 | — | terminated | Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual. |
| Aug 11, 2006 | Z-1535-06 | — | terminated | Audible alarm may not sound during an alert condition |
| Sep 2, 2002 | Z-1049-04 | — | terminated | Audio alarm may fail to sound when SpO2 limits drop below the set limits |