Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

BSF · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

53 daysmedian FDA review time

168 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K951093	KAB SYSTEM	King Systems Corp.	1995-03-24	15
K852071	OHMEDA GMS ABOSORBER	Ohmeda Medical	1985-07-15	63
K843422	OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR	Ohmeda Medical	1984-10-23	53
K834535	NITROUS OXIDE RECYCLER	G & L Unltd.	1984-06-07	168
K833452	OHIO GMS ABSORBER	Airco/Ohio Medical Products	1983-11-29	67
K821144	OHIO ABSORBER	Ohio Medical Products	1982-05-28	37
K801255	PENLON JUMBO CARBON DIOXIDE ABSORBER	Penlon, Inc.	1980-06-04	7
K760076	ABSORBER, ANESTHESIA CIRCLE SYS, CO2	Fraser Sweatman, Inc.	1976-07-16	28

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