Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GYK — Predicate Candidate Screening

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

37 daysmedian FDA review time

102 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K962761	REIGEL TUNNELING DEVICE	Cook, Inc.	1996-10-11	87	0
K934391	V/P AND L/P CATHETER PASSERS	Radionics, Inc.	1993-11-19	71	0
K930606	PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER	Pudenz-Schulte Medical Research Corp.	1993-09-10	217	0
K932273	CORDIS TUNNELER	Cordis Corp.	1993-08-23	102	0
K895868	HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE	Baxter Healthcare Corp	1989-10-31	27	0
K883607	PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER	Codman & Shurtleff, Inc.	1988-09-30	38	0
K873771	HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO	American V. Mueller	1987-12-18	93	0
K865075	H-H SUBGALEAL TROCAR	Holter-Hausner Intl.	1987-01-13	15	0
K853370	H-H CATHETER PASSERS(TACL DESIGN	Holter-Hausner Intl.	1985-09-18	37	2
K853368	H-H SHUNT INTRODUCER	Holter-Hausner Intl.	1985-09-06	25	0
K841553	H-H SHUNT PASSERS	Holter-Hausner Intl.	1984-05-14	28	0
K792639	H-H SHUNT INTRODUCER	Holter-Hausner Intl.	1979-12-31	11	0
K771529	PERITONEAL INTRODUCER & SHEATH	Cordis Corp.	1977-08-16	8	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