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

Circulatory Technology, Inc. — Predicate Candidate Screening

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

126 daysmedian FDA review time

537 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K140321	INITARY BETTER BLADDER-PEDIATRIC	Circulatory Technology, Inc.	2014-04-17	58	0
K012942	THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTE	Circulatory Technology, Inc.	2001-11-05	66	0
K001822	THE V-BAG	Circulatory Technology, Inc.	2000-07-07	21	0
K981284	BETTER-BLADDER (BB)	Circulatory Technology, Inc.	1998-08-12	126	4
K964205	BETTER-TUBING	Circulatory Technology, Inc.	1998-04-08	537	0
K964337	BETTER-BLADDER (BB)	Circulatory Technology, Inc.	1997-05-23	204	0
K961594	BETTER-VENTER	Circulatory Technology, Inc.	1996-09-05	134	0
K941492	PRESSURE RELIEF VALVE	Circulatory Technology, Inc.	1994-10-26	212	0
K942933	PRESSURE INFUSION CUFF	Circulatory Technology, Inc.	1994-08-25	64	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