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

DQT — Predicate Candidate Screening

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

121 daysmedian FDA review time

151 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K983927	GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT	Arterial Vascular Engineering, Inc.	1999-03-11	126	2
K945963	THE OMNIGUIDE GUIDING CATHETER WITH BALLOON	Micro Interventional Systems, Inc.	1995-02-08	63	0
K910916	CATHLAB SILICONE OCCLUSION BALLOON CATHETER	Cathlab Corp.	1991-06-24	111	0
K910339	AVD INTIMAX OCCLUSION CATHETER	Applied Vascular Devices, Inc.	1991-05-29	121	0
K880860	CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015	Dlp, Inc.	1988-05-26	86	0
K880231	MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER	Ideas For Medicine, Inc.	1988-05-25	133	1
K872090	THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT	Ideas For Medicine, Inc.	1987-10-30	151	1
K872790	PERFUSION CATHETER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-09-15	63	0
K872154	MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH	Ideas For Medicine, Inc.	1987-08-03	63	0
K863559	URESIL OCCLUSION BALLOON CATHETER	Uresil Corp.	1986-10-10	28	0
K844918	OCCLUSION & OCCLUSION-IRRIGATION	Clincal Instruments Corp.	1985-08-05	229	0
K840795	ACS SOF-T GUIDE WIREE	Advanced Cardiovascular Systems, Inc.	1984-07-02	130	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