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

KGC — Predicate Candidate Screening

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

90 daysmedian FDA review time

225 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K242211	PUMA-G Pediatric System	Coaptech, Inc.	2025-04-29	274	0
K223916	PUMA-G System	Coaptech, Inc.	2023-03-29	90	0
K193612	AMT Suture Delivery System	Applied Medical Technology, Inc.	2020-03-12	77	0
K191844	Fidmi Low Profile Enteral Feeding Device	Fidmi Medical, Ltd.	2019-09-30	83	0
K182832	Cope Pediatric Gastrointestinal Suture Anchor Set, Enterosto	Cook Incorporated	2019-06-26	260	0
K183057	PUMA-G System	Coaptech, LLC	2019-04-10	159	0
K170323	Entuit Start Initial Placement Gastrostomy Set	Cook Incorporated	2017-09-14	225	0
K120587	AMT T-FASTENER ANCHOR KIT	Applied Medical Technology, Inc.	2012-05-25	88	0
K093312	KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY F	Kimberly-Clark Corp.	2009-12-08	47	0
K073718	MEDLINE GASTROSTOMY TUBE	Medline Industries, Inc.	2008-03-19	79	0
K080253	KIMBERLY-CLARK INTRODUCER KITS	Kimberly-Clark Corp.	2008-02-26	26	0
K980145	AMT DECOMPRESSION TUBES	Applied Medical Technology, Inc.	1998-04-10	85	0
K910492	BARD REPLACEMENT GASTROSTOMY TUBE	C.R. Bard, Inc.	1991-07-24	169	4
K910584	ONE STEP BUTTON(TM)	Applied Medical Technologies	1991-05-23	101	6
K904779	BUTTON REPLACEMENT GASTROSTOMY DEVICE	C.R. Bard, Inc.	1991-01-18	88	5
K904801	ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE	Orion Life Systems, Inc.	1991-01-16	84	0
K903086	TUBE GASTROSTOMY	Knight Medical, Inc.	1990-11-20	131	0
K903036	P.R.G. GUIDEWIRE PLACEMENT SYSTEM	Applied Medical Technologies	1990-11-19	131	0
K901795	GASTROSTOMY FEEDING CATHETER	Southside Biotechnology	1990-08-08	111	0
K901791	PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH.	Southside Biotechnology	1990-08-08	111	0
K902121	LAKE GASTROSTOMY TUBE	Lake Medical Products, Inc.	1990-07-27	77	0
K900884	P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY	Applied Medical Technologies	1990-07-02	126	0
K901501	CORPAK GASTROSTOMY TUBE	Corpak Co.	1990-06-11	73	0
K894653	NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR	Superior Biosystems, Inc.	1989-12-21	150	0
K860441	ENTROKIT WITH MAGLINTE CATHETER	Lafayette Pharmacal, Inc.	1986-03-12	36	0
K781333	CENTRAL CATHETER TRAY	Argon Medical Corp.	1978-10-24	83	2

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