Cleared Traditional

K190310 - 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.

K190310 · U Deliver Medical, LLC · Gastroenterology & Urology device
May 2019
Decision
108d
Days
Class 2
Risk

K190310 is an FDA 510(k) clearance for the U Deliver Bolink ENFit Enteral Feeding Sets. This device is classified as a Gastrointestinal Tubes With Enteral Specific Connectors (Class II - Special Controls, product code PIF).

Submitted by U Deliver Medical, LLC (Hopkins, US). The FDA issued a Cleared decision on May 31, 2019, 108 days after receiving the submission on February 12, 2019.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. To Facilitate Enteral Specific Connections..

Submission Details

510(k) Number K190310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2019
Decision Date May 31, 2019
Days to Decision 108 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 156d · This submission: 108d
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 K190310.
Percutaneous Endoscopic Gastrostomy (PEG) Kit
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