Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

NZA — Predicate Candidate Screening

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

108 daysmedian FDA review time

231 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232918	enspire 300 Series Automated Endoscope Reprocessor	STERIS Corporation	2023-10-03	14	0
K230560	enspire 300 Series Automated Endoscope Reprocessor System	STERIS Corporation	2023-07-21	143	0
K220361	Reliance EPS Endoscope Processing System and Reliance DG Dry	STERIS Corporation	2022-03-10	30	0
K203223	Reliance EPS Endoscope Processing System and Reliance DG Dry	Steris	2021-01-28	87	0
K200989	Reliance Endoscope Processing System	STERIS Corporation	2020-05-14	29	0
K123768	RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM	STERIS Corporation	2013-07-26	231	0
K110453	RELIANCE ENDOSCOPE PROCESSING SYSTEM	STERIS Corporation	2011-03-16	28	1
K102244	RELIANCE ENDOSCOPE PROCESSING SYSTEM	STERIS Corporation	2010-12-03	116	1
K040049	THE RELIANCE ENDOSCOPE PROCESSING SYSTEM	STERIS Corporation	2004-12-17	340	2
K860704	THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND	Keymed, Inc.	1986-06-17	111	0
K841331	OLYMPUS KC-10 MOBILE DISINFEC-STAT	Keymed, Inc.	1984-07-19	108	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