Cleared Traditional

K163586 - Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector

K163586 is an FDA 510(k) clearance for Trovita Health Science Safe-T Feed Read..., manufactured by Trovrx, Inc. Dba Trovita Health Science. The device is a Class 2 Gastroenterology & Urology device with product code PIF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K163586 · Trovrx, Inc. Dba Trovita Health Science · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
87d
Days
Class 2
Risk

K163586 is an FDA 510(k) clearance for the Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Trovrx, Inc. Dba Trovita Health Science (Philadelphia, US). The FDA issued a Cleared decision on March 17, 2017 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trovrx, Inc. Dba Trovita Health Science devices

FDA 510(k) Submission Details - K163586

510(k) Number K163586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2016
Decision Date March 17, 2017
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
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

Libramedical, Inc.
Julie Bodmer

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 51
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K163586.
Vesco Medical Nasoenteric Feeding Tubes
K170162 · Vesco Medical, LLC · Sep 2017
U Deliver Bolink ENFit Enteral Feeding Sets
K170555 · U Deliver Medical, LLC · Aug 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
Edi Catheter ENFit
K153688 · Maquet Critical Care AB · Mar 2017
Medline ENFit Syringe
K160642 · Medline Industries, Inc. · Nov 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
K161003 · Boston Scientific Corporation · Jun 2016