510(k) Report

FDA applicant

Novametrix Medical Systems, Inc.

Wallingford, CT45 decisions1978–200134 recalls

FDA records 45 decisions for Novametrix Medical Systems, Inc. (Wallingford, CT) from 1978 to 2001: 45 510(k) clearances. Most are in product codes KLK (Monitor, Oxygen, Cutaneous, For Infant Not…) and DQA (Oximeter). Its devices cite 3 predicates, 1 of them its own earlier devices. 34 recalls are linked to its devices.

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 Novametrix Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Novametrix Medical Systems, Inc. since 2007.

Recalls per year

32in 2009

2009: 32
2007high 32 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Novametrix Medical Systems, 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?

  • KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia13decisions
  • DQAOximeter8decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase5decisions
  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)4decisions
  • BZCCalculator, Pulmonary Function Data4decisions
  • DSFRecorder, Paper Chart2decisions

Also: CAP (2), BZD (1), JOM (1), DRG (1), CCL (1), GWF (1).

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 1 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.

  • K963327Tidal Wave Carbon Dioxide Monitor, Model 610Novametrix Medical Systems, Inc. · 19964cite it
  • K993979MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20004cite it
  • K982499Cosmo Plus with Nico, Model 8200Novametrix Medical Systems, Inc. · 19983cite it
  • K963380CO 2 Smo PlusNovametrix Medical Systems, Inc. · 19973cite it
  • K853124Novametrix Pulse Oximeter, Model 500Novametrix Medical Systems, Inc. · 19853cite it
  • K000794Modification to MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20002cite it

What has FDA decided for it lately?

  • K010451Novametrix Marquette Compatible SensorsNovametrix Medical Systems, Inc. · 2001
  • K000794Modification to MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20005 recalls
  • K993979MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20001 recall
  • K982499Cosmo Plus with Nico, Model 8200Novametrix Medical Systems, Inc. · 19981 recall
  • K964360Vent (Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101Novametrix Medical Systems, Inc. · 1997
  • K963380CO 2 Smo PlusNovametrix Medical Systems, Inc. · 19973 recalls
  • K963327Tidal Wave Carbon Dioxide Monitor, Model 610Novametrix Medical Systems, Inc. · 19964 recalls
  • K960831Ventrak RMMS 1550Novametrix Medical Systems, Inc. · 1996

All 45 as Novametrix Medical Systems, Inc. →

What has been recalled?

34 recalls linked to its devices; the latest:

  • K890517Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product. Used for trending O2…Nov 19, 2009
  • K963380REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of…Nov 19, 2009
  • K893643515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product. Intended use is to…Nov 19, 2009
  • K963327Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors…Nov 19, 2009
  • K913516100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product. Intended…Nov 19, 2009
  • K920379Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products. Intended to be…Nov 19, 2009