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

DTI — Predicate Candidate Screening

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

86 daysmedian FDA review time

204 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K952184	CARBOMEDICS SUPRA-ANNULAR VALVE SIZER	Carbomedics, Inc.	1995-11-29	204
K934951	VALVE SIZER	Carbomedics, Inc.	1993-12-10	53
K881279	EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET	Baxter Healthcare Corp	1988-05-18	57
K853313	DUROMEDICS CARDIAC VALVE SIZER SET	Hemex Scientific, Inc.	1985-11-01	86
K852612	METRONIC MODEL F7700 HEART VALVE SIZERS	Medtronic Vascular	1985-09-23	96
K820887	MITRAL VALVE ORIFICE SIZER	Celtech	1982-07-08	100
K801885	HANCOCK * OBTURATORS	Hancock Laboratories, Inc.	1980-09-09	33

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