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

Circon Acmi — Predicate Candidate Screening

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

92 daysmedian FDA review time

281 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K013165	USA SERIES LAPAROSCOPES	Circon Acmi	2002-01-18	119	0
K980492	AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F,	Circon Acmi	1998-11-17	281	4
K905706	GYN-1500 HYSTEROSCOPIC INUFFLATOR	Circon Acmi	1991-02-28	66	0
K905705	LAP 3501 HIGH FLOW INSUFFLATOR	Circon Acmi	1991-02-28	66	0
K884097	MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES	Circon Acmi	1989-04-17	201	0
K884025	CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200	Circon Acmi	1989-03-03	162	0
K884254	CIRCON ACMI BICAP III THERAPEUTIC SYSTEM	Circon Acmi	1989-01-11	92	0
K884252	CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20	Circon Acmi	1989-01-10	91	0
K884306	BICAP ABLATING FORCEPS BAF-7	Circon Acmi	1989-01-05	84	0
K883819	BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P	Circon Acmi	1988-10-17	39	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