510(k) Report

FDA applicant

Respironics Novametrix, Inc.

Wallingford, CT11 decisions2003–201125 recalls

FDA records 11 decisions for Respironics Novametrix, Inc. (Wallingford, CT) from 2003 to 2011: 11 510(k) clearances. Most are in product codes BZK (Spirometer, Monitoring (W/Wo Alarm)) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 19 predicates, 6 of them its own earlier devices. 25 recalls are linked to its devices.

FDA’s records also spell it “Respironics Novametrix, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Respironics Novametrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12009: 22011: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2011

2009: 172010: 22011: 4
2007high 17 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Respironics Novametrix, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Respironics Novametrix, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • BZKSpirometer, Monitoring (W/Wo Alarm)4decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase4decisions
  • DQAOximeter3decisions

Whose devices does it build on?

Its devices cite 19 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042601Capnostat 5Respironics Novametrix, Inc. · 20048cite it
  • K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC · 20067cite it
  • K030886Nico with Mars, Model 7300Respironics Novametrix, Inc. · 20036cite it
  • K032971Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 20044cite it
  • K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 20112cite it
  • K080652Mercury VCO2 Module with Capnostat 5Respironics Novametrix, LLC · 20081cites it

What has FDA decided for it lately?

  • K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
  • K092217Mercury VCO2Respironics Novametrix, Inc. · 20094 recalls
  • K091459Philips NM3 Monitor, Model 7900Respironics Novametrix, LLC · 20094 recalls
  • K080652Mercury VCO2 Module with Capnostat 5Respironics Novametrix, LLC · 20084 recalls
  • K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC · 20062 recalls
  • K042601Capnostat 5Respironics Novametrix, Inc. · 20041 recall
  • K032971Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 20047 recalls
  • K032949Spot Check Pulse Oximeter,512/513Respironics Novametrix, Inc. · 20042 recalls

All 7 as Respironics Novametrix, Inc. →All 4 as Respironics Novametrix, LLC →

What has been recalled?

25 recalls linked to its devices; the latest:

  • K080652FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005Jul 29, 2011
  • K080652PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674…Jul 29, 2011
  • K080652Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3…Jan 4, 2011
  • K080652Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3…Jan 4, 2011
  • K032949Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00Sep 27, 2010
  • K032949Dixtal Handheld Pulse Oximetry Model 512 Catalog Number: 9100-00Sep 27, 2010

Other applicant names beginning “Respironics”

FDA records each applicant name separately; these may or may not be the same firm.

Respironics, Inc. 174Respironics Inc., Sleep & Home Respiratory Group 21Respironics California, Inc. 11Respironics New Jersey, Inc. 5Respironics Respiratory Drug Delivery (Uk), Ltd. 2Respironics Healthscan, Inc. 2Respironics Georgia, Inc. 2Respironics Inc. (Dba Philips Respironics) 1Respironics (Ireland) Limited 1