Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Respironics Novametrix, Inc. — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

200 daysmedian FDA review time

339 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K092217	MERCURY VCO2	Respironics Novametrix, Inc.	2009-08-21	30	4
K042601	CAPNOSTAT 5	Respironics Novametrix, Inc.	2004-11-19	56	1
K032971	TIDAL WAVE SP MODEL 710/715 AND 715	Respironics Novametrix, Inc.	2004-08-26	339	7
K032949	SPOT CHECK PULSE OXIMETER,512/513	Respironics Novametrix, Inc.	2004-08-23	336	2
K041450	MODIFICATION TO NICO WITH MARS, MODEL 7300	Respironics Novametrix, Inc.	2004-06-18	17	1
K032755	MODEL 509M PULSE OXIMETER, MODEL 509M	Respironics Novametrix, Inc.	2004-05-21	259	1
K030886	NICO WITH MARS, MODEL 7300	Respironics Novametrix, Inc.	2003-10-07	200	8

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