Cleared Traditional

K190310 - U Deliver Bolink ENFit Enteral Feeding ...

K190310 is the FDA 510(k) clearance for U Deliver Bolink ENFit Enteral Feeding ... by U Deliver Medical, LLC. It is a Class 2 Gastroenterology & Urology device (product code PIF) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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

K190310 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 (Hopkins, US). The FDA issued a Cleared decision on May 31, 2019 after a review of 108 days - within the typical 510(k) review window.

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

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 130d · 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 Consultant

Vista Regulatory Solutions, LLC
Thomas Dold

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 36
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K190310.
Gabriel Feeding Tube with Balloon, and EnFit Connector
K191784 · Syncro Medical Innovations, Inc. · Nov 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
K190923 · Cardinalhealth · Nov 2019
Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
K190414 · Moss Tubes, Inc. · Jun 2019
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K181787 · Cedic S.R.L. · Apr 2019
ENConnect 40 mm Screw Cap to ENPlus Adapter
K190327 · Cedic S.R.L. · Apr 2019
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