FPD · Class II · 21 CFR 876.5980

FDA Product Code FPD: Tube, Feeding

Leading manufacturers include Sandoz Nutrition, Vygon Corp. and Corpak Medsystems.

59
Total
59
Cleared
167d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 51d recently vs 169d historically

FDA 510(k) Cleared Tube, Feeding Devices (Product Code FPD)

59 devices
1–24 of 59
Cleared Dec 19, 2024
Nutrifit
K243361
Vygon USA
Gastroenterology & Urology · 51d
Cleared Jan 18, 2019
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
K180236
Vr Medical Technology Co., Ltd.
Gastroenterology & Urology · 354d
Cleared Oct 23, 2013
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
K131590
Philips Medical Systems
Gastroenterology & Urology · 145d
Cleared Mar 06, 2013
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
K120815
Philips Medical Systems
Gastroenterology & Urology · 352d
Cleared Dec 18, 2012
NUTRISAFE 2 FEEDING TUBE
K121105
Vygon Corp.
Gastroenterology & Urology · 250d
Cleared Oct 13, 2011
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
K100163
Vygon Corp.
Gastroenterology & Urology · 631d
Cleared May 13, 2011
VR MEDICAL ENTERAL ORAL SYRINGE
K110853
Vr Medical
Gastroenterology & Urology · 46d
Cleared Jun 09, 2009
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340
Boston Scientific Corp
Gastroenterology & Urology · 34d
Cleared Mar 05, 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
K083776
Corpak Medsystems
Gastroenterology & Urology · 76d
Cleared Mar 04, 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
K083791
Corpak Medsystems
Gastroenterology & Urology · 75d
Cleared Feb 20, 2009
CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB
K083786
Corpak Medsystems
Gastroenterology & Urology · 63d
Cleared Dec 29, 2008
CORFLO ANTI IV ENTERAL FEEDING TUBE
K083210
Corpak Medsystems
Gastroenterology & Urology · 59d
Cleared Dec 12, 2008
FROG
K072831
Newby-Coombs, LLC
Gastroenterology & Urology · 436d
Cleared Oct 01, 2008
NEOMED POLYURETHANE FEEDING TUBE
K082238
Neomed, Inc.
Gastroenterology & Urology · 55d
Cleared Jan 09, 2008
NEOMED Enteral FEEDING TUBE
K072881
Neomed, Inc.
Gastroenterology & Urology · 92d
Cleared Jul 23, 2007
NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT
K071191
Novartis Nutrition Corp.
Gastroenterology & Urology · 84d
Cleared Sep 15, 2006
NUTRISAFE 2
K060944
Vygon Corp.
Gastroenterology & Urology · 162d
Cleared Jan 11, 2002
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311
Vygon Corp.
Gastroenterology & Urology · 445d
Cleared Feb 04, 1999
NUTRISAFE ENTERAL FEEDING TUBE
K981629
Schiff & Co.
Gastroenterology & Urology · 273d
Cleared Jan 26, 1998
ROSS ENTERAL FEEDING TUBE
K972437
Ross Products
Gastroenterology & Urology · 210d
Cleared Aug 20, 1997
JEJENOSTOMY FEEDING TUBE
K971906
Boston Scientific Corp
Gastroenterology & Urology · 89d
Cleared May 23, 1997
RUSCH ENTERAL FEEDING TUBE
K963779
Rusch, Inc.
Gastroenterology & Urology · 245d
Cleared Jan 11, 1996
INFANT FEEDING TUBE
K953008
Marquette Medical, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 03, 1995
STERILE FEEDING TUBE
K954218
Baxter Healthcare Corp
Gastroenterology & Urology · 56d

About Product Code FPD - Regulatory Context

510(k) Submission Activity

59 total 510(k) submissions under product code FPD since 1976, with 59 receiving FDA clearance (average review time: 167 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FPD Product Code

Recent submissions under FPD have taken an average of 51 days to reach a decision - down from 169 days historically, suggesting improved FDA processing for this classification.

FPD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →