PIF · Class II · 21 CFR 876.5980

FDA Product Code PIF: Gastrointestinal Tubes With Enteral Specific Connectors

To Facilitate Enteral Specific Connections.

Leading manufacturers include Covidien, Medline Industries, Inc. and Xeridiem Medical Devices, A Spectrum Plastics Group Company.

50
Total
50
Cleared
169d
Avg days
2014
Since
Declining activity - 3 submissions in the last 2 years vs 7 in the prior period
Review times improving: avg 137d recently vs 170d historically

FDA 510(k) Cleared Gastrointestinal Tubes With Enteral Specific Connectors Devices (Product Code PIF)

50 devices
1–24 of 50
Cleared Mar 20, 2026
Percutaneous Endoscopic Gastrostomy (PEG) Kit
K254170
Degania Silicone , Ltd.
Gastroenterology & Urology · 87d
Cleared Jun 18, 2025
Enteral Drainage System, Enteral Medicine straw
K242917
Hmc Premedical S.P.A.
Gastroenterology & Urology · 267d
Cleared Apr 18, 2025
Extension Feeding Set with ENFit™ Connectors
K250481
SKY Medical, a.s.
Gastroenterology & Urology · 58d
Cleared Jul 03, 2024
Disposable Enteral Feeding Sets
K240052
Beijing L&Z Medical Technology Development Co., Ltd.
Gastroenterology & Urology · 177d
Cleared Apr 12, 2024
Mobility+ Enteral Feeding System OTC
K233034
Rockfield Medical
Gastroenterology & Urology · 200d
Cleared Nov 02, 2023
ENFit to ENFit Extension Sets
K230326
Vesco Medical
Gastroenterology & Urology · 269d
Cleared Oct 06, 2023
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
K232046
Xeridiem Medical Devices, A Spectrum Plastics Group Company
Gastroenterology & Urology · 88d
Cleared Aug 17, 2023
Feeding Tube
K222773
Anhui Tiankang Medical Technology Co., Ltd.
Gastroenterology & Urology · 337d
Cleared Jul 10, 2023
EnteraLoc Flow
K223683
Vonco Products
Gastroenterology & Urology · 214d
Cleared Oct 27, 2022
Mobility+ Enteral Feeding System
K222678
Rockfield Medical
Gastroenterology & Urology · 51d
Cleared Jun 09, 2022
Nasogastric Feeding Tubes - ENFit Port - PVC
K213258
Cair Lgl
Gastroenterology & Urology · 252d
Cleared May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174
Cardinalhealth
Gastroenterology & Urology · 233d
Cleared Jan 20, 2022
Entuit PEG, Entuit PEGJ
K213356
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 100d
Cleared Nov 16, 2021
Enteral Feeding Set
K210854
Kb Medical (Group), Inc.
Gastroenterology & Urology · 238d
Cleared Nov 02, 2021
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
K210598
Cair Lgl
Gastroenterology & Urology · 246d
Cleared Aug 19, 2021
Enteral Extension Sets
K203633
GBUK Group, Ltd.
Gastroenterology & Urology · 251d
Cleared Aug 18, 2021
EnteraLoc Flow
K210971
Vonco Products
Gastroenterology & Urology · 140d
Cleared Nov 05, 2020
Gabriel 3 Way EnFit Valve
K201741
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 133d
Cleared Oct 01, 2020
Nutricare Clear-ISOSAF Nasogastric Feeding Tube
K202357
Three Circles Consulting Limited
Gastroenterology & Urology · 43d
Cleared Aug 03, 2020
Vesco Medical Extension Feeding Set
K192991
Vesco Medical, LLC
Gastroenterology & Urology · 283d
Cleared Jul 30, 2020
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
K200082
Mps Medical, Inc.
Gastroenterology & Urology · 197d
Cleared Dec 04, 2019
Medline Quick Switch Valve with ENFit Connector
K191759
Medline Industries, Inc.
Gastroenterology & Urology · 156d
Cleared Nov 15, 2019
Gabriel Feeding Tube with Balloon, and EnFit Connector
K191784
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 135d
Cleared Nov 07, 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
K190923
Cardinalhealth
Gastroenterology & Urology · 212d

About Product Code PIF - Regulatory Context

510(k) Submission Activity

50 total 510(k) submissions under product code PIF since 2014, with 50 receiving FDA clearance (average review time: 169 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 7 in the prior period.

FDA 510(k) Review Time - PIF Product Code

Recent submissions under PIF have taken an average of 137 days to reach a decision - down from 170 days historically, suggesting improved FDA processing for this classification.

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