Cleared Traditional

K170555 - U Deliver Bolink ENFit Enteral Feeding Sets

K170555 is an FDA 510(k) clearance for U Deliver Bolink ENFit Enteral Feeding Sets, manufactured by U Deliver Medical, LLC. The device is a Class 2 Gastroenterology & Urology device with product code PIF cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K170555 · U Deliver Medical, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all U Deliver Medical, LLC devices

FDA 510(k) Submission Details - K170555

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 131d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PIF Device Classification - Class 2, Special Controls

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 Consultant

Donawa Lifescience Consulting Srl
Roger Gray

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 50
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K170555.
Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
K180708 · Xeridiem Medical Devices, A Spectrum Plastics Group Company · Oct 2018
CONOD Enteral Feeding Sets
K181276 · Conod Medical Co., Limited · Jul 2018
Vesco Medical Nasoenteric Feeding Tubes
K170162 · Vesco Medical, LLC · Sep 2017
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
K171347 · Xeridiem Medical Devices · Jun 2017
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
K163586 · Trovrx, Inc. Dba Trovita Health Science · Mar 2017
Edi Catheter ENFit
K153688 · Maquet Critical Care AB · Mar 2017