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

Acmi Corporation — Predicate Candidate Screening

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

78 daysmedian FDA review time

111 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061975	PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK	Acmi Corporation	2006-08-10	28	0
K060752	ACMI DUR-HL LASER SYSTEMS	Acmi Corporation	2006-05-25	65	0
K060269	ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM	Acmi Corporation	2006-03-31	58	0
K051593	UROPASS URETERAL ACCESS SHEATH, MODEL 61224	Acmi Corporation	2005-09-02	78	2
K052044	ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL	Acmi Corporation	2005-08-16	19	0
K043581	DUAL LUMEN CATHETER	Acmi Corporation	2005-03-03	65	1
K042069	INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM	Acmi Corporation	2004-11-01	91	0
K042225	ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565	Acmi Corporation	2004-09-10	24	0
K031758	ACMI M4 TELESCOPES	Acmi Corporation	2003-09-02	88	0
K030960	ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE	Acmi Corporation	2003-07-16	111	0
K030935	BERKELEY V-10 VACUUM CURETTAGE SYSTEM	Acmi Corporation	2003-06-23	90	0
K030684	SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH	Acmi Corporation	2003-06-03	90	0
K031001	ACMI VISTA CTR BIPOLAR LOOP ELECTRODE	Acmi Corporation	2003-05-21	51	0
K023358	USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR	Acmi Corporation	2003-01-03	88	0
K022480	ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC	Acmi Corporation	2002-08-22	27	0
K012018	BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910	Acmi Corporation	2002-07-16	383	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