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

FPD — Predicate Candidate Screening

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

123 daysmedian FDA review time

386 days90th percentile

59clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243361	Nutrifit	Vygon USA	2024-12-19	51	0
K180236	VR Medical Feeding Tube and Enteral Feeding Extension Set (E	Vr Medical Technology Co., Ltd.	2019-01-18	354	0
K131590	INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE	Philips Medical Systems	2013-10-23	145	0
K120815	INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE	Philips Medical Systems	2013-03-06	352	0
K121105	NUTRISAFE 2 FEEDING TUBE	Vygon Corp.	2012-12-18	250	0
K100163	NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX	Vygon Corp.	2011-10-13	631	0
K110853	VR MEDICAL ENTERAL ORAL SYRINGE	Vr Medical	2011-05-13	46	0
K100700	MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES	Benlan, Inc.	2010-12-13	276	1
K101214	GUARDIAN CONNECTION	Maulin Medical, LLC	2010-07-23	84	0
K100099	ORAL/ENTERAL SYRINGES	Philips Children'S Medical Ventures	2010-06-14	152	0
K100526	AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE	Kentec Medical, Inc.	2010-04-22	57	2
K091340	THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M0056	Boston Scientific Corp	2009-06-09	34	0
K083776	CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S	Corpak Medsystems	2009-03-05	76	0
K083791	CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S	Corpak Medsystems	2009-03-04	75	0
K083786	CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006	Corpak Medsystems	2009-02-20	63	0
K083210	CORFLO ANTI IV ENTERAL FEEDING TUBE	Corpak Medsystems	2008-12-29	59	0
K072831	FROG	Newby-Coombs, LLC	2008-12-12	436	0
K082238	NEOMED POLYURETHANE FEEDING TUBE	Neomed, Inc.	2008-10-01	55	1
K072881	NEOMED Enteral FEEDING TUBE	Neomed, Inc.	2008-01-09	92	0
K071191	NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUB	Novartis Nutrition Corp.	2007-07-23	84	0
K060944	NUTRISAFE 2	Vygon Corp.	2006-09-15	162	2
K003311	NUTRISAFE PUR ENTERAL FEEDING TUBE	Vygon Corp.	2002-01-11	445	0
K981629	NUTRISAFE ENTERAL FEEDING TUBE	Schiff & Co.	1999-02-04	273	0
K972437	ROSS ENTERAL FEEDING TUBE	Ross Products	1998-01-26	210	0
K971906	JEJENOSTOMY FEEDING TUBE	Boston Scientific Corp	1997-08-20	89	0
K963779	RUSCH ENTERAL FEEDING TUBE	Rusch, Inc.	1997-05-23	245	0
K953008	INFANT FEEDING TUBE	Marquette Medical, Inc.	1996-01-11	197	0
K954218	STERILE FEEDING TUBE	Baxter Healthcare Corp	1995-11-03	56	0
K922402	4 SURE TM ENTERAL FEEDING BAG	Boston Pacific Medical, Inc.	1994-03-25	673	0
K915308	PEG GASTROSTOMY TUBE KIT	Sandoz Nutrition	1993-03-12	477	0
K914492	GASTROINTESTINAL TUBE AND ACCESSORIES	Sandoz Nutrition	1992-02-25	140	0
K915439	NASOGASTRIC FEEDING TUBE KITS	Sandoz Nutrition	1992-02-25	85	1
K913407	NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE	Sandoz Nutrition	1992-02-25	210	0
K915438	FEEDING TUBE Y-PORT CONNECTOR	Sandoz Nutrition	1992-02-24	84	0
K913701	MOSS - ANCHOR SET	Moss Medical Products	1992-02-14	179	0
K914482	STOMA MEASURING DEVICE	Biosearch Medical Products, Inc.	1991-12-27	80	0
K912575	EXTERNAL GASTROSTOMY TUBE RETAINER	Sandoz Nutrition	1991-11-21	162	0
K912972	FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE	Abbott Laboratories	1991-09-23	77	0
K905677	JEJUNO-CATH KIT	Health Improvement Assoc.	1991-08-09	233	0
K896734	FEEDING TUBE	Unoplast A/S	1990-12-21	386	0
K901163	WILSON-COOK PULL THROUGH PEG KIT	Wilson-Cook Medical, Inc.	1990-11-19	251	0
K895923	METRICARE ENTERAL FEEDING SYSTEM	Metrix Co.	1990-07-19	281	0
K897181	L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE	Intl. Medical Marketing, Inc.	1990-03-27	89	0
K896559	INFANT FEEDING TUBE	Westmark, Sterile Packing Systems, Inc. (Sps)	1990-03-13	116	0
K895824	L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET	Intl. Medical Marketing, Inc.	1990-03-13	165	0
K894860	WILTEK GASTRIC FEEDING TUBE	Wiltek Medical, Inc.	1989-12-21	143	0
K894939	PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY	North American Sterilization & Packaging Co.	1989-12-08	127	0
K890396	EXTERNAL FEEDING SET FOR PUMP USE	Multi-Med, Inc.	1989-05-23	119	0
K892431	KENDALL CURITY FEEDING TUBES	The Kendal Co.	1989-05-19	39	0
K890116	ENTERAL FEEDING TUBE	Hdc Corp.	1989-04-05	84	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