Cleared Traditional

Edi Catheter ENFit (K153688) - FDA 510(k) Clearance

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

K153688 · Maquet Critical Care AB · Gastroenterology & Urology device
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Mar 2017
Decision
435d
Days
Class 2
Risk

K153688 is an FDA 510(k) clearance for the Edi Catheter ENFit. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on March 2, 2017 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Maquet Critical Care AB devices

Submission Details

510(k) Number K153688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date March 02, 2017
Days to Decision 435 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
305d slower than avg
Panel avg: 130d · This submission: 435d
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

All 37
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K153688.
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
CONOD Enteral Feeding Sets
K181276 · Conod Medical Co., Limited · Jul 2018
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
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
K150711 · Covidien · Oct 2015