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

Optical Sensors, Inc. · Predicate Candidate Screening

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

226 daysmedian FDA review time

729 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040654	SENSILASE PAD 3000	Optical Sensors, Inc.	2004-06-04	84	0
K010795	CAPNOPROBE SL, MODEL 2000	Optical Sensors, Inc.	2001-04-11	26	1
K984579	CAPNO PROBE A	Optical Sensors, Inc.	2000-12-21	729	0
K961790	POINT-OF-CARE BLOOD GAS MONITOR SYSTEM	Optical Sensors, Inc.	1997-04-09	335	0
K963935	OLYMPUS CRITICAL CARE MONITORING SYSTEM	Optical Sensors, Inc.	1997-01-23	114	0
K951094	POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM	Optical Sensors, Inc.	1996-01-16	313	0
K931185	SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE	Optical Sensors, Inc.	1993-10-21	226	0

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