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

American Sterilizer Co. — Predicate Candidate Screening

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

31 daysmedian FDA review time

154 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K943288	AMSCO SQ240 SURGICAL LIGHT	American Sterilizer Co.	1994-10-17	101	0
K931872	THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER	American Sterilizer Co.	1994-02-07	299	0
K922485	CHEMDI-VHP CHEMICAL INDICATOR	American Sterilizer Co.	1993-09-29	499	0
K930493	QUANTUM 3080 SURGICAL TABLE	American Sterilizer Co.	1993-06-22	141	0
K905816	ORTHOVISION TABLE	American Sterilizer Co.	1991-03-06	68	0
K896674	AMSCO QUANTUM LIGHT	American Sterilizer Co.	1990-01-03	37	0
K895164	EAGLE DS	American Sterilizer Co.	1989-11-17	87	0
K882660	GENERAL SURGICAL TABLE AND ACCESSORIES	American Sterilizer Co.	1988-07-25	27	0
K880198	GEMINI SURGICAL LIGHT	American Sterilizer Co.	1988-02-10	26	0
K864846	RADIOGRAPHIC - LEG SECTION	American Sterilizer Co.	1986-12-24	14	0
K844479	CHEMSPOR	American Sterilizer Co.	1985-11-25	371	0
K852127	AMSCO URO-ENDO MOBILE TABLE	American Sterilizer Co.	1985-08-08	85	0
K850144	BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH	American Sterilizer Co.	1985-06-17	154	0
K851340	BLUE SEAL II STERILIZATION POUCH	American Sterilizer Co.	1985-04-24	21	0
K844512	DART DAILY AIR REMOVAL TEST	American Sterilizer Co.	1985-03-21	121	0
K850143	SPORDEX CULTURE MEDIA	American Sterilizer Co.	1985-03-05	50	0
K844411	SCRUB MATE DRY STERILE SCRUB BRUSH	American Sterilizer Co.	1984-12-17	33	0
K843439	CENTURIAN HYDRAULIC STRETCHER	American Sterilizer Co.	1984-09-13	9	0
K841360	MINOR SURGICAL LIGHT MODEL 180	American Sterilizer Co.	1984-04-24	22	0
K841156	VANTAGE E	American Sterilizer Co.	1984-04-13	25	0
K832816	HALL ARTHROTOME	American Sterilizer Co.	1983-11-28	101	0
K823772	AMSCO ORTHOGRAPHIC 2 TABLE	American Sterilizer Co.	1983-01-14	31	0
K823902	EAGLE STERISET	American Sterilizer Co.	1983-01-09	10	0
K823074	CHEMDI STEAM & GAS STERILIZATION INDICA	American Sterilizer Co.	1982-11-08	20	0
K821749	AMSCO ENDOSCOPY TABLE	American Sterilizer Co.	1982-07-09	24	0
K801063	HALL ARTERIAL OSCILLATOR	American Sterilizer Co.	1980-09-26	143	0
K801428	CHEMDI	American Sterilizer Co.	1980-08-13	57	0
K800275	CEBOTOME DRILL	American Sterilizer Co.	1980-02-19	12	0
K792028	OTOTOME BUR	American Sterilizer Co.	1979-10-26	17	0
K781979	SURGAIRTOME TWO	American Sterilizer Co.	1978-12-20	23	2
K781698	EXAMINER 10	American Sterilizer Co.	1978-11-03	24	0
K781684	STERILIZER, EAGLE 2000	American Sterilizer Co.	1978-10-24	22	0
K781699	EAGLE PAC/VISIBLE SEAL	American Sterilizer Co.	1978-10-24	13	0
K781581	SURGICAL LIGHT 22 SERIES	American Sterilizer Co.	1978-10-17	32	0
K772324	WIREDRIVER	American Sterilizer Co.	1978-01-03	15	0
K771915	MICRO OSCILLATING SAW	American Sterilizer Co.	1977-10-21	9	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