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

LDS — Predicate Candidate Screening

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

155 daysmedian FDA review time

354 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K183444	Cenorin 610 Washer-Pasteurizers/High Level Disinfector and C	Cenorin, LLC	2019-09-09	271
K031799	MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881	Miele, Inc.	2003-11-12	155
K983068	RELIANCE FAMILY OF WASHER-DISINFECTORS	STERIS Corporation	2000-05-31	637
K972193	OLYMPIX MINI-PASTEURMATIC (58210)	Olympic Medical Corp.	1997-09-05	87
K950518	MIELE G 7781 DENTAL THERMAL DISINFECTOR	Miele Professional	1996-01-26	354
K950566	DECOMAT 4656	Getinge Disinfection, Inc.	1995-10-19	253
K953645	OLYMPIC PASTEURMATIC SYSTEM	Olympic Medical Corp.	1995-09-22	49
K884151	MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.	Miele Appliances, Inc.	1989-05-16	225
K860263	CASTLE 7538 FLOOR LOADING WASHER	Castle Co.	1986-03-05	37
K844089	CASTLE 7515 UTENSIL/GLASSWARE WASHER	Castle Co.	1985-01-14	84
K810311	STERI-VERS	The Hilrad Co.	1981-04-17	71

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