Tube, Feeding
FDA product code FPD · Class II (moderate risk) · 21 CFR 876.5980 · Gastroenterology, Urology
59510(k) clearances
0PMA approvals
23recalls
Manufacturers
- Sandoz Nutrition 6
- Corpak Medsystems 4
- Vygon Corp. 4
- Boston Scientific Corporation 2
- Biosearch Medical Products, Inc. 2
- Philips Medical Systems 2
- Neomed, Inc. 2
- Intl. Medical Marketing, Inc. 2
- The Kendal Co. 1
- Unoplast A/S 1
- Wilson-Cook Medical, Inc. 1
- Wiltek Medical, Inc. 1
- North American Sterilization & Packaging Co. 1
- Multi-Med, Inc. 1
- Sherwood Medical Industries 1
- Stereotactic Medical Systems, Inc. 1
- Plasco, Inc. 1
- Henley Board, Inc. 1
- G.D. Searle and Co. 1
- Vygon USA 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243361 | NutrifitFPD · Traditional | Vygon USA | 12/19/2024SE |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)FPD · Traditional | Vr Medical Technology Co., Ltd. | 01/18/2019SE |
| K131590 | Innersense Esophageal Temperature Probe / Feeding TubeFPD · Traditional | Philips Medical Systems | 10/23/2013SE |
| K120815 | Innersense Esophageal Temperature/Feeding TubeFPD · Traditional | Philips Medical Systems | 03/06/2013SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | Vygon Corp. | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | Vygon Corp. | 10/13/2011SE |
| K110853 | VR Medical Enteral Oral SyringeFPD · Traditional | Vr Medical | 05/13/2011SE |
| K100700 | Med-Rx Pediatric Feeding Tubes and AccessoriesFPD · Traditional | Benlan, Inc. | 12/13/2010SE |
| K101214 | Guardian ConnectionFPD · Traditional | Maulin Medical, LLC | 07/23/2010SE |
| K100099 | Oral/Enteral SyringesFPD · Traditional | Philips Children'S Medical Ventures | 06/14/2010SE |
| K100526 | Ameritus Entral (TM) Enteral Feeding TubeFPD · Traditional | Kentec Medical, Inc. | 04/22/2010SE |
| K091340 | Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330, M00566340…FPD · Special | Boston Scientific Corp | 06/09/2009SESK |
| K083776 | Corflo Anti IV Enteral Feeding Set, Model: 20-1030AIV-LB-SFPD · Traditional | Corpak Medsystems | 03/05/2009SE |
| K083791 | Corflo Anti IV Enteral Feeding Set, Model: 20-1060AIV-SFPD · Traditional | Corpak Medsystems | 03/04/2009SE |
| K083786 | Corflo Anti-Iv Enteral Feeding Extension Set, Models 20-1006AIV-LB and 20-1030AIV-LBFPD · Traditional | Corpak Medsystems | 02/20/2009SE |
| K083210 | Corflo Anti IV Enteral Feeding TubeFPD · Traditional | Corpak Medsystems | 12/29/2008SE |
| K072831 | FrogFPD · Traditional | Newby-Coombs, LLC | 12/12/2008SE |
| K082238 | Neomed Polyurethane Feeding TubeFPD · Special | Neomed, Inc. | 10/01/2008SE |
| K072881 | NEOMED Enteral FEEDING TUBEFPD · Traditional | Neomed, Inc. | 01/09/2008SE |
| K071191 | Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube KitFPD · Traditional | Novartis Nutrition Corp. | 07/23/2007SE |
| K060944 | Nutrisafe 2FPD · Special | Vygon Corp. | 09/15/2006SE |
| K003311 | Nutrisafe Pur Enteral Feeding TubeFPD · Traditional | Vygon Corp. | 01/11/2002SE |
| K981629 | Nutrisafe Enteral Feeding TubeFPD · Traditional | Schiff & Co. | 02/04/1999SE |
| K972437 | Ross Enteral Feeding TubeFPD · Traditional | Ross Products | 01/26/1998SE |
| K971906 | Jejenostomy Feeding TubeFPD · Traditional | Boston Scientific Corp | 08/20/1997SE |
| K963779 | Rusch Enteral Feeding TubeFPD · Traditional | Rusch, Inc. | 05/23/1997SE |
| K953008 | Infant Feeding TubeFPD · Traditional | Marquette Medical, Inc. | 01/11/1996SE |
| K954218 | Sterile Feeding TubeFPD · Traditional | Baxter Healthcare Corp | 11/03/1995SE |
| K922402 | 4 Sure TM Enteral Feeding BagFPD · Traditional | Boston Pacific Medical, Inc. | 03/25/1994SE |
| K915308 | Peg Gastrostomy Tube KitFPD · Traditional | Sandoz Nutrition | 03/12/1993SESK |
| K915439 | Nasogastric Feeding Tube KitsFPD · Traditional | Sandoz Nutrition | 02/25/1992SESK |
| K914492 | Gastrointestinal Tube and AccessoriesFPD · Traditional | Sandoz Nutrition | 02/25/1992SESK |
| K913407 | Nasojejunal Feeding Tube W/Gastric DrainageFPD · Traditional | Sandoz Nutrition | 02/25/1992SESK |
| K915438 | Feeding Tube Y-Port ConnectorFPD · Traditional | Sandoz Nutrition | 02/24/1992SE |
| K913701 | Moss - Anchor SetFPD · Traditional | Moss Medical Products | 02/14/1992SE |
| K914482 | Stoma Measuring DeviceFPD · Traditional | Biosearch Medical Products, Inc. | 12/27/1991SE |
| K912575 | External Gastrostomy Tube RetainerFPD · Traditional | Sandoz Nutrition | 11/21/1991SE |
| K912972 | Flexiflo Over the Guidewire Jejunal Feeding TubeFPD · Traditional | Abbott Laboratories | 09/23/1991SE |
| K905677 | Jejuno-Cath KitFPD · Traditional | Health Improvement Assoc. | 08/09/1991SE |
| K896734 | Feeding TubeFPD · Traditional | Unoplast A/S | 12/21/1990SE |
| K901163 | Wilson-Cook Pull Through Peg KitFPD · Traditional | Wilson-Cook Medical, Inc. | 11/19/1990SESD |
| K895923 | Metricare Enteral Feeding SystemFPD · Traditional | Metrix Co. | 07/19/1990SE |
| K897181 | L.T.C. Percutaneous Endoscopic Gastrostomy TubeFPD · Traditional | Intl. Medical Marketing, Inc. | 03/27/1990SESD |
| K896559 | Infant Feeding TubeFPD · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 03/13/1990SE |
| K895824 | L.T.C. Enteral Bag Administration Set W/Pump SetFPD · Traditional | Intl. Medical Marketing, Inc. | 03/13/1990SE |
| K894860 | Wiltek Gastric Feeding TubeFPD · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
| K894939 | Percutaneous Endoscopic Gastrostomy TrayFPD · Traditional | North American Sterilization & Packaging Co. | 12/08/1989SE |
| K890396 | External Feeding Set for Pump UseFPD · Traditional | Multi-Med, Inc. | 05/23/1989SE |
| K892431 | Kendall Curity Feeding TubesFPD · Traditional | The Kendal Co. | 05/19/1989SE |
| K890116 | Enteral Feeding TubeFPD · Traditional | Hdc Corp. | 04/05/1989SE |
| K884415 | EP-100 (Series)FPD · Traditional | Stereotactic Medical Systems, Inc. | 02/28/1989SE |
| K870623 | Enteral Administration SetFPD · Traditional | Plasco, Inc. | 06/26/1987SE |
| K862090 | Mcgaw Nutra-Feed Efs Enteral Feeding BagFPD · Traditional | Kendall Mcgaw Laboratories, Inc. | 10/03/1986SE |
| K852100 | The Henley Board S.I.D. Spinal Immobilization DeviFPD · Traditional | Henley Board, Inc. | 07/24/1985SE |
| K810131 | Administration SetFPD · Traditional | G.D. Searle and Co. | 02/26/1981SE |
| K781385 | Dobbhoff Enteric Feeding BagFPD · Traditional | Biosearch Medical Products, Inc. | 09/07/1978SE |
| K780415 | Vivonex Delivery SystemFPD · Traditional | Norwich Pharmacal Co. | 04/10/1978SE |
| K770620 | Tubing Feeding KitFPD · Traditional | Doyle Pharmaceutical | 05/03/1977SE |
| K760137 | Tube, Feeding, ArgyleFPD · Traditional | Sherwood Medical Industries | 07/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1722-2022 Class II | MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral…Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. | ICU Medical, Inc. | 08/01/2022Open, Classified |
| Z-2520-2020 Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and…Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1)… | Kentec Medical, Inc | 01/17/2020Terminated |
| Z-2519-2020 Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and…Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1)… | Kentec Medical, Inc | 01/17/2020Terminated |
| Z-2518-2020 Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and…Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1)… | Kentec Medical, Inc | 01/17/2020Terminated |
| Z-2517-2020 Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and…Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1)… | Kentec Medical, Inc | 01/17/2020Terminated |
| Z-2516-2020 Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and…Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1)… | Kentec Medical, Inc | 01/17/2020Terminated |
| Z-2515-2020 Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and…Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1)… | Kentec Medical, Inc | 01/17/2020Terminated |
| Z-2514-2020 Class II | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and…Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1)… | Kentec Medical, Inc | 01/17/2020Terminated |
| Z-2293-2019 Class II | DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF…Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector… | DeRoyal Industries Inc | 07/22/2019Terminated |
| Z-2281-2019 Class II | MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16"…The firm received a complaint that the connector detached from the feeding tube. | Canadian Hospital Specialties | 07/16/2019Terminated |
| Z-1036-2019 Class II | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray…An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | ConvaTec, Inc | 01/09/2019Open, Classified |
| Z-0746-2019 Class II | DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding…Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. | DeRoyal Industries Inc | 12/17/2018Terminated |
| Z-0725-2019 Class II | MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and…The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as… | Canadian Hospital Specialties | 12/01/2018Terminated |
| Z-2440-2018 Class II | MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use…The product may be packaged with the incorrect length of feeding tube as labeled. | Canadian Hospital Specialties | 06/11/2018Terminated |
| Z-0093-2019 Class II | NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr…Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors… | Neomed Inc | 06/04/2018Terminated |
| Z-1357-2018 Class II | Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R)…BMD has identified that the product code/lot number combination identified above may have ineffectively… | C.R. Bard, Inc. | 02/27/2018Terminated |
| Z-1356-2018 Class II | Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R)…BMD has identified that the product code/lot number combination identified above may have ineffectively… | C.R. Bard, Inc. | 02/27/2018Terminated |
| Z-1355-2018 Class II | Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric…BMD has identified that the product code/lot number combination identified above may have ineffectively… | C.R. Bard, Inc. | 02/27/2018Terminated |
| Z-1354-2018 Class II | Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R)…BMD has identified that the product code/lot number combination identified above may have ineffectively… | C.R. Bard, Inc. | 02/27/2018Terminated |
| Z-3074-2017 Class II | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a)…Inadequate detectability of radiopaque stripes | Kentec Medical Inc | 06/23/2017Terminated |
| Z-3073-2017 Class II | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50…Inadequate detectability of radiopaque stripes | Kentec Medical Inc | 06/23/2017Terminated |
| Z-0595-2016 Class II | MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For…The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size. | Benlan, Inc. | 12/11/2015Terminated |
| Z-1922-2013 Class II | Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10…Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they have been… | Nestle HealthCare Nutrition | 07/24/2013Terminated |