Product Code: FPD FDA class 2 21 CFR 876.5980

Tube, Feeding

Gastroenterology, Urology

The Feeding Tube is a flexible catheter inserted through the nose or mouth into the stomach or small intestine to deliver liquid nutrition or medication to patients unable to swallow or take nutrition orally. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPD, regulated under 21 CFR 876.5980 in the Gastroenterology and Urology specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FPD
Device Class: FDA class 2
Regulation Number: 876.5980
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 59 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243361	Nutrifit	Dec 19, 2024	Substantially Equivalent	Vygon USA
K180236	VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)	Jan 18, 2019	Substantially Equivalent	Vr Medical Technology Co., Ltd.
K131590	INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE	Oct 23, 2013	Substantially Equivalent	Philips Medical Systems
K120815	INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE	Mar 06, 2013	Substantially Equivalent	Philips Medical Systems
K121105	NUTRISAFE 2 FEEDING TUBE	Dec 18, 2012	Substantially Equivalent	Vygon Corp.
K100163	NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX	Oct 13, 2011	Substantially Equivalent	Vygon Corp.
K110853	VR MEDICAL ENTERAL ORAL SYRINGE	May 13, 2011	Substantially Equivalent	Vr Medical
K100700	MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES	Dec 13, 2010	Substantially Equivalent	Benlan, Inc.
K101214	GUARDIAN CONNECTION	Jul 23, 2010	Substantially Equivalent	Maulin Medical, LLC
K100099	ORAL/ENTERAL SYRINGES	Jun 14, 2010	Substantially Equivalent	Philips Children'S Medical Ventures
K100526	AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE	Apr 22, 2010	Substantially Equivalent	Kentec Medical, Inc.
K091340	THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350	Jun 09, 2009	Unknown	Boston Scientific Corp
K083776	CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S	Mar 05, 2009	Substantially Equivalent	Corpak Medsystems
K083791	CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S	Mar 04, 2009	Substantially Equivalent	Corpak Medsystems
K083786	CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB	Feb 20, 2009	Substantially Equivalent	Corpak Medsystems
K083210	CORFLO ANTI IV ENTERAL FEEDING TUBE	Dec 29, 2008	Substantially Equivalent	Corpak Medsystems
K072831	FROG	Dec 12, 2008	Substantially Equivalent	Newby-Coombs, LLC
K082238	NEOMED POLYURETHANE FEEDING TUBE	Oct 01, 2008	Substantially Equivalent	Neomed, Inc.
K072881	NEOMED Enteral FEEDING TUBE	Jan 09, 2008	Substantially Equivalent	Neomed, Inc.
K071191	NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT	Jul 23, 2007	Substantially Equivalent	Novartis Nutrition Corp.
K060944	NUTRISAFE 2	Sep 15, 2006	Substantially Equivalent	Vygon Corp.
K003311	NUTRISAFE PUR ENTERAL FEEDING TUBE	Jan 11, 2002	Substantially Equivalent	Vygon Corp.
K981629	NUTRISAFE ENTERAL FEEDING TUBE	Feb 04, 1999	Substantially Equivalent	Schiff & Co.
K972437	ROSS ENTERAL FEEDING TUBE	Jan 26, 1998	Substantially Equivalent	Ross Products
K971906	JEJENOSTOMY FEEDING TUBE	Aug 20, 1997	Substantially Equivalent	Boston Scientific Corp
K963779	RUSCH ENTERAL FEEDING TUBE	May 23, 1997	Substantially Equivalent	Rusch, Inc.
K953008	INFANT FEEDING TUBE	Jan 11, 1996	Substantially Equivalent	Marquette Medical, Inc.
K954218	STERILE FEEDING TUBE	Nov 03, 1995	Substantially Equivalent	Baxter Healthcare Corp
K922402	4 SURE TM ENTERAL FEEDING BAG	Mar 25, 1994	Substantially Equivalent	Boston Pacific Medical, Inc.
K915308	PEG GASTROSTOMY TUBE KIT	Mar 12, 1993	Unknown	Sandoz Nutrition
K915439	NASOGASTRIC FEEDING TUBE KITS	Feb 25, 1992	Unknown	Sandoz Nutrition
K914492	GASTROINTESTINAL TUBE AND ACCESSORIES	Feb 25, 1992	Unknown	Sandoz Nutrition
K913407	NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE	Feb 25, 1992	Unknown	Sandoz Nutrition
K915438	FEEDING TUBE Y-PORT CONNECTOR	Feb 24, 1992	Substantially Equivalent	Sandoz Nutrition
K913701	MOSS - ANCHOR SET	Feb 14, 1992	Substantially Equivalent	Moss Medical Products
K914482	STOMA MEASURING DEVICE	Dec 27, 1991	Substantially Equivalent	Biosearch Medical Products, Inc.
K912575	EXTERNAL GASTROSTOMY TUBE RETAINER	Nov 21, 1991	Substantially Equivalent	Sandoz Nutrition
K912972	FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE	Sep 23, 1991	Substantially Equivalent	Abbott Laboratories
K905677	JEJUNO-CATH KIT	Aug 09, 1991	Substantially Equivalent	Health Improvement Assoc.
K896734	FEEDING TUBE	Dec 21, 1990	Substantially Equivalent	Unoplast A/S
K901163	WILSON-COOK PULL THROUGH PEG KIT	Nov 19, 1990	Unknown	Wilson-Cook Medical, Inc.
K895923	METRICARE ENTERAL FEEDING SYSTEM	Jul 19, 1990	Substantially Equivalent	Metrix Co.
K897181	L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE	Mar 27, 1990	Unknown	Intl. Medical Marketing, Inc.
K896559	INFANT FEEDING TUBE	Mar 13, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K895824	L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET	Mar 13, 1990	Substantially Equivalent	Intl. Medical Marketing, Inc.
K894860	WILTEK GASTRIC FEEDING TUBE	Dec 21, 1989	Substantially Equivalent	Wiltek Medical, Inc.
K894939	PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY	Dec 08, 1989	Substantially Equivalent	North American Sterilization & Packaging Co.
K890396	EXTERNAL FEEDING SET FOR PUMP USE	May 23, 1989	Substantially Equivalent	Multi-Med, Inc.
K892431	KENDALL CURITY FEEDING TUBES	May 19, 1989	Substantially Equivalent	The Kendal Co.
K890116	ENTERAL FEEDING TUBE	Apr 05, 1989	Substantially Equivalent	Hdc Corp.
K884415	EP-100 (SERIES)	Feb 28, 1989	Substantially Equivalent	Stereotactic Medical Systems, Inc.
K870623	ENTERAL ADMINISTRATION SET	Jun 26, 1987	Substantially Equivalent	Plasco, Inc.
K862090	MCGAW NUTRA-FEED EFS ENTERAL FEEDING BAG	Oct 03, 1986	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K852100	THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI	Jul 24, 1985	Substantially Equivalent	Henley Board, Inc.
K810131	ADMINISTRATION SET	Feb 26, 1981	Substantially Equivalent	G.D. Searle and Co.
K781385	DOBBHOFF ENTERIC FEEDING BAG	Sep 07, 1978	Substantially Equivalent	Biosearch Medical Products, Inc.
K780415	VIVONEX DELIVERY SYSTEM	Apr 10, 1978	Substantially Equivalent	Norwich Pharmacal Co.
K770620	TUBING FEEDING KIT	May 03, 1977	Substantially Equivalent	Doyle Pharmaceutical
K760137	TUBE, FEEDING, ARGYLE	Jul 16, 1976	Substantially Equivalent	Sherwood Medical Industries