Novametrix Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Novametrix Medical Systems, Inc.” (first 1978, latest 2001), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 69 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 13 | 13 |
| DQA | Oximeter | 8 | 8 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 5 | 5 |
| BZC | Calculator, Pulmonary Function Data | 4 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| DSF | Recorder, Paper Chart | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
Plus 4 more product codes.
Review panels
- Anesthesiology (36)
- Cardiovascular (8)
- Neurology (1)
Most recent Novametrix Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010451 | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS | DQA | 2001-04-25 | 69 |
| K000794 | MODIFICATION TO MARSPO2, MODEL 2001 | DQA | 2000-04-10 | 28 |
| K993979 | MARSPO2, MODEL 2001 | DQA | 2000-02-22 | 90 |
| K982499 | COSMO PLUS WITH NICO, MODEL 8200 | BZC | 1998-10-16 | 88 |
| K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 | BZC | 1997-04-04 | 154 |
| K963380 | CO 2 SMO PLUS | BZC | 1997-01-22 | 148 |
| K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 | CCK | 1996-11-20 | 89 |
| K960831 | VENTRAK RMMS 1550 | BZC | 1996-05-29 | 90 |
| K924626 | NOVAMETRIX MODEL 510 | DQA | 1993-12-03 | 445 |
| K920379 | NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX | DQA | 1992-07-15 | 168 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Novametrix Medical Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Novametrix Medical Systems, Inc.?
FDA lists 45 510(k) clearances under the applicant name “Novametrix Medical Systems, Inc.” (first 1978, latest 2001), across 14 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Novametrix Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novametrix Medical Systems, Inc. is 69 days.
Which FDA product codes appear under Novametrix Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia, 13); DQA (Oximeter, 8); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 5).
Next steps
- See all 45 Novametrix Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KLK, Novametrix Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.