Atlas FDA

FPD

59 FDA 510(k) clearances · Product code

123 daysmedian time to decision
386 days90th percentile
59clearances measured

FDA profile

Official device name
Tube, Feeding
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2020: 31 · 2021: 24 · 2022: 19 · 2023: 55 · 2024: 41 · 2026: 74
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Nutrifit (K243361)Vygon USA2024-12-19
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (K180236)Vr Medical Technology Co., Ltd.2019-01-18
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (K131590)Philips Medical Systems2013-10-23
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (K120815)Philips Medical Systems2013-03-06
NUTRISAFE 2 FEEDING TUBE (K121105)Vygon Corp.2012-12-18
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (K100163)Vygon Corp.2011-10-13
VR MEDICAL ENTERAL ORAL SYRINGE (K110853)Vr Medical2011-05-13
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (K100700)Benlan, Inc.2010-12-13
GUARDIAN CONNECTION (K101214)Maulin Medical, LLC2010-07-23
ORAL/ENTERAL SYRINGES (K100099)Philips Children'S Medical Ventures2010-06-14
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (K100526)Kentec Medical, Inc.2010-04-22
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 (K091340)Boston Scientific Corp2009-06-09
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S (K083776)Corpak Medsystems2009-03-05
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S (K083791)Corpak Medsystems2009-03-04
CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB (K083786)Corpak Medsystems2009-02-20
CORFLO ANTI IV ENTERAL FEEDING TUBE (K083210)Corpak Medsystems2008-12-29
FROG (K072831)Newby-Coombs, LLC2008-12-12
NEOMED POLYURETHANE FEEDING TUBE (K082238)Neomed, Inc.2008-10-01
NEOMED Enteral FEEDING TUBE (K072881)Neomed, Inc.2008-01-09
NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT (K071191)Novartis Nutrition Corp.2007-07-23
NUTRISAFE 2 (K060944)Vygon Corp.2006-09-15
NUTRISAFE PUR ENTERAL FEEDING TUBE (K003311)Vygon Corp.2002-01-11
NUTRISAFE ENTERAL FEEDING TUBE (K981629)Schiff & Co.1999-02-04
ROSS ENTERAL FEEDING TUBE (K972437)Ross Products1998-01-26
JEJENOSTOMY FEEDING TUBE (K971906)Boston Scientific Corp1997-08-20
RUSCH ENTERAL FEEDING TUBE (K963779)Rusch, Inc.1997-05-23
INFANT FEEDING TUBE (K953008)Marquette Medical, Inc.1996-01-11
STERILE FEEDING TUBE (K954218)Baxter Healthcare Corp1995-11-03
4 SURE TM ENTERAL FEEDING BAG (K922402)Boston Pacific Medical, Inc.1994-03-25
PEG GASTROSTOMY TUBE KIT (K915308)Sandoz Nutrition1993-03-12
GASTROINTESTINAL TUBE AND ACCESSORIES (K914492)Sandoz Nutrition1992-02-25
NASOGASTRIC FEEDING TUBE KITS (K915439)Sandoz Nutrition1992-02-25
NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE (K913407)Sandoz Nutrition1992-02-25
FEEDING TUBE Y-PORT CONNECTOR (K915438)Sandoz Nutrition1992-02-24
MOSS - ANCHOR SET (K913701)Moss Medical Products1992-02-14
STOMA MEASURING DEVICE (K914482)Biosearch Medical Products, Inc.1991-12-27
EXTERNAL GASTROSTOMY TUBE RETAINER (K912575)Sandoz Nutrition1991-11-21
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE (K912972)Abbott Laboratories1991-09-23
JEJUNO-CATH KIT (K905677)Health Improvement Assoc.1991-08-09
FEEDING TUBE (K896734)Unoplast A/S1990-12-21
WILSON-COOK PULL THROUGH PEG KIT (K901163)Wilson-Cook Medical, Inc.1990-11-19
METRICARE ENTERAL FEEDING SYSTEM (K895923)Metrix Co.1990-07-19
L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (K897181)Intl. Medical Marketing, Inc.1990-03-27
INFANT FEEDING TUBE (K896559)Westmark, Sterile Packing Systems, Inc. (Sps)1990-03-13
L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET (K895824)Intl. Medical Marketing, Inc.1990-03-13
WILTEK GASTRIC FEEDING TUBE (K894860)Wiltek Medical, Inc.1989-12-21
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY (K894939)North American Sterilization & Packaging Co.1989-12-08
EXTERNAL FEEDING SET FOR PUMP USE (K890396)Multi-Med, Inc.1989-05-23
KENDALL CURITY FEEDING TUBES (K892431)The Kendal Co.1989-05-19
ENTERAL FEEDING TUBE (K890116)Hdc Corp.1989-04-05
EP-100 (SERIES) (K884415)Stereotactic Medical Systems, Inc.1989-02-28
ENTERAL ADMINISTRATION SET (K870623)Plasco, Inc.1987-06-26
MCGAW NUTRA-FEED EFS ENTERAL FEEDING BAG (K862090)Kendall Mcgaw Laboratories, Inc.1986-10-03
THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI (K852100)Henley Board, Inc.1985-07-24
ADMINISTRATION SET (K810131)G.D. Searle and Co.1981-02-26
DOBBHOFF ENTERIC FEEDING BAG (K781385)Biosearch Medical Products, Inc.1978-09-07
VIVONEX DELIVERY SYSTEM (K780415)Norwich Pharmacal Co.1978-04-10
TUBING FEEDING KIT (K770620)Doyle Pharmaceutical1977-05-03
TUBE, FEEDING, ARGYLE (K760137)Sherwood Medical Industries1976-07-16

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Every clearance here is in the API, with alerts when new ones post.