Respironics Novametrix, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Respironics Novametrix, Inc.” (first 2003, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 105 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Philips, based on public ownership records.
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 |
|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 4 | 4 |
| DQA | Oximeter | 3 | 3 |
Review panels
- Anesthesiology (11)
Most recent Respironics Novametrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | BZK | 2011-06-02 | 178 |
| K092217 | MERCURY VCO2 | BZK | 2009-08-21 | 30 |
| K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | BZK | 2009-07-28 | 71 |
| K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | BZK | 2008-06-20 | 105 |
| K053174 | LOFLO C5 CO2 SENSOR | CCK | 2006-01-12 | 59 |
| K042601 | CAPNOSTAT 5 | CCK | 2004-11-19 | 56 |
| K032971 | TIDAL WAVE SP MODEL 710/715 AND 715 | DQA | 2004-08-26 | 339 |
| K032949 | SPOT CHECK PULSE OXIMETER,512/513 | DQA | 2004-08-23 | 336 |
| K041450 | MODIFICATION TO NICO WITH MARS, MODEL 7300 | CCK | 2004-06-18 | 17 |
| K032755 | MODEL 509M PULSE OXIMETER, MODEL 509M | DQA | 2004-05-21 | 259 |
1 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2011-07-29.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Respironics, Inc. (173 510(k)s)
- Respironics Inc., Sleep & Home Respiratory Group (21 510(k)s)
- Respironics California, Inc. (11 510(k)s)
- Respironics New Jersey, Inc. (5 510(k)s)
- Respironics Georgia, Inc. (2 510(k)s)
- Respironics Healthscan, Inc. (2 510(k)s)
- Respironics Respiratory Drug Delivery (Uk) , Ltd. (2 510(k)s)
- Respironics Inc. (Dba Philips Respironics) (1 510(k)s)
- Respironics (Ireland) Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Respironics Novametrix, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Respironics Novametrix, Inc.” (first 2003, latest 2011), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Respironics Novametrix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Respironics Novametrix, Inc. is 105 days.
Which FDA product codes appear under Respironics Novametrix, Inc.?
The most frequent FDA product codes under this applicant name are BZK (Spirometer, Monitoring (W/Wo Alarm), 4); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 4); DQA (Oximeter, 3).
Next steps
- See all 11 Respironics Novametrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZK, Respironics Novametrix, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.