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

Case Medical, Inc. · Predicate Candidate Screening

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

245 daysmedian FDA review time

304 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252854	SteriTite Container System with MediTray Products	Case Medical, Inc.	2026-06-03	268	0
K221492	SteriTite Container System with MediTray Parts	Case Medical, Inc.	2022-10-07	137	0
K212711	SteriTite Container System with MediTray Products	Case Medical, Inc.	2022-04-29	246	0
K173259	Case Medical SteriTite Reusable Rigid Sterilization Containe	Case Medical, Inc.	2018-06-13	246	0
K161415	SteriTite Containers System & MediTray Products	Case Medical, Inc.	2017-02-10	263	0
K112904	STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS	Case Medical, Inc.	2012-01-24	112	0
K110682	STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS	Case Medical, Inc.	2011-07-01	113	0
K090068	STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS	Case Medical, Inc.	2010-02-24	411	0
K080558	STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS	Case Medical, Inc.	2008-12-05	281	1
K022978	STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY	Case Medical, Inc.	2003-05-09	245	0
K023614	STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM	Case Medical, Inc.	2003-04-07	161	1
K030853	STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTA	Case Medical, Inc.	2003-03-21	3	1
K991023	STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CON	Case Medical, Inc.	2000-01-27	304	0
K982151	STERITITE PROCESS INDICATOR ACCESSORIES	Case Medical, Inc.	1999-02-09	236	0
K974638	STERITITE SEALED CONTAINERS MODEL SCO4Q	Case Medical, Inc.	1997-12-18	69	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