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

Scimed — Predicate Candidate Screening

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

86 daysmedian FDA review time

265 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K992142	SCIMED ANGIOGRAPHIC CATHETERS	Scimed	1999-07-21	27	0
K953909	SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER	Scimed	1995-11-13	84	0
K931584	SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.	Scimed	1993-07-01	92	1
K922706	SCIMED SIDELINER	Scimed	1992-12-10	188	0
K915347	SCIMED VIPER CATHETER	Scimed	1992-08-17	265	0
K910987	7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE	Scimed	1991-05-29	83	0
K904171	SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM	Scimed	1990-12-06	86	0
K903503	SCIMED ENCORE INFLATION DEVICE, MODEL SM2500	Scimed	1990-10-09	67	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