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

NVE — Predicate Candidate Screening

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

201 daysmedian FDA review time

270 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K222849	AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Ster	Steris	2022-09-30	9	0
K222543	AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Ster	Steris	2022-08-25	3	0
K203199	RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7	STERIS Corporation	2020-12-01	33	0
K200577	RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP	STERIS Corporation	2020-04-03	29	0
K190081	RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/705	STERIS Corporation	2019-08-21	217	0
K073112	DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253	Intuitive Surgical, Inc.	2008-08-01	270	0
K043314	MANZI CLEANER SYSTEM	Langford IC Systems, Inc.	2005-06-20	201	0
K983017	MODIFICATION TO SYSTEM 83 PLUS	Custom Ultrasonics	1998-09-22	25	2
K871712	MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.	Machida America, Inc.	1988-01-14	255	0
K861821	KEYMED FIBERSCOPE AUTO DISINFECTOR	Keymed, Inc.	1987-02-12	276	0
K862402	OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES	Medivators, Inc.	1987-02-03	223	0
K832458	AUTOMATIC ENDOSCOPE	American Endoscopy, Inc.	1983-10-20	86	2

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