Cleared Traditional

K170555 - U Deliver Bolink ENFit Enteral Feeding Sets (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170555 · U Deliver Medical, LLC · Gastroenterology & Urology device
Aug 2017
Decision
174d
Days
Class 2
Risk

K170555 is an FDA 510(k) clearance for the U Deliver Bolink ENFit Enteral Feeding Sets. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by U Deliver Medical, LLC (Woodbury, US). The FDA issued a Cleared decision on August 17, 2017 after a review of 174 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K170555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2017
Decision Date August 17, 2017
Days to Decision 174 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 156d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PIF Gastrointestinal Tubes With Enteral Specific Connectors

Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K170555.
Percutaneous Endoscopic Gastrostomy (PEG) Kit
K254170 · Degania Silicone , Ltd. · Mar 2026
Enteral Drainage System, Enteral Medicine straw
K242917 · Hmc Premedical S.P.A. · Jun 2025
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K250481 · SKY Medical, a.s. · Apr 2025
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174 · Cardinalhealth · May 2022
Entuit PEG, Entuit PEGJ
K213356 · Wilson-Cook Medical, Inc. · Jan 2022