Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Respironics Novametrix, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | Respironics Novametrix, LLC | 2011-06-02 | 178 | 0 |
| K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | Respironics Novametrix, LLC | 2009-07-28 | 71 | 4 |
| K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | Respironics Novametrix, LLC | 2008-06-20 | 105 | 4 |
| K053174 | LOFLO C5 CO2 SENSOR | Respironics Novametrix, LLC | 2006-01-12 | 59 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda