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

LKG · Predicate Candidate Screening

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

103 daysmedian FDA review time

205 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K950315	CORDIS CSF RESERVOIR	Cordis Corp.	1995-05-09	103	0
K881690	PORT-A-CATH PORTAL INTRODUCER FORCEPS	Pharmacia Deltec, Inc.	1988-05-20	31	0
K881493	PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.	Pharmacia Deltec, Inc.	1988-05-20	42	0
K874468	P-S MEDICAL VENTRICULAR ACCESS PORT	Pudenz-Schulte Medical Research Corp.	1988-02-11	101	0
K874498	CSF-VENTRICULOSTOMY RESERVOIR	Pudenz-Schulte Medical Research Corp.	1988-02-11	101	29
K833822	P-S MEDICAL CSF ACCESS DEV 15MM/25MM	Pudenz-Schulte Medical Research Corp.	1984-05-25	205	0
K833672	HH SUBCUTANEOUS ACCESS PORT	Holter-Hausner Intl.	1984-03-06	140	0
K823790	VENTRICULAR ACCESS SYSTEM	American Heyer Schulte	1983-04-28	133	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