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

JCY · Predicate Candidate Screening

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

84 daysmedian FDA review time

91 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K863982	VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY	Vas-Cath of Canada , Ltd.	1986-10-24	10
K840324	SILICONE SUMP DRAIN 20 & 40 FRENCH	Superior Plastic Products Corp.	1984-04-25	91
K834615	TRIPLE LUMEN INFUSIONCATHETERS-	Medical Components, Inc.	1984-02-14	72
K831453	SILCATH CENTRAL CATHETER TRAY W/18 GA	Argon Medical Corp.	1983-07-28	84
K831451	SILCATH CENTRAL CATHETER TRAY SIZE-	Argon Medical Corp.	1983-06-08	34
K822096	CHEMOTHERAPY INFUSION CATHETER	American Heyer Schulte	1983-04-12	270
K813606	SILICONE ELASTOMER INFUSION CATHETER	Quest Medical, Inc.	1982-01-18	20
K791372	JELCO & KVO CATHETER PLACEMENT UNIT	Jelco Laboratories	1979-09-12	50
K771861	CATHETER, CEBTRAL VENOUS, 2N1501	Travenol Laboratories, S.A.	1977-11-28	56
K760760	CATHETER, INTRAVASCULAR (ARGYLE IV SK)	Sherwood Medical Industries	1976-12-09	66
K760391	CATHETER, VEIN (BRAUNULA)	B. Braun Instruments	1976-11-02	89
K760380	INTRAVENOUS TRANSFER SET (INTRAFIX)	B. Braun Instruments	1976-11-02	89
K760381	BLOOD TRANSFUSION SET (SANGOFIX)	B. Braun Instruments	1976-11-02	89
K760390	CATHETER, VEIN (BRAUNULA T)	B. Braun Instruments	1976-11-02	89

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