Cleared Traditional

ENTAKE STANDARD AND SAFETY PEG SYSTEM (K061021) - FDA 510(k) Clearance

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

K061021 · Conmedcorp · Gastroenterology & Urology device
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Apr 2006
Decision
15d
Days
Class 2
Risk

K061021 is an FDA 510(k) clearance for the ENTAKE STANDARD AND SAFETY PEG SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Conmedcorp (Billerica, US). The FDA issued a Cleared decision on April 28, 2006 after a review of 15 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 Conmedcorp devices

Submission Details

510(k) Number K061021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2006
Decision Date April 28, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 145
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K061021.
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
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K072476 · Boston Scientific Corporation · Dec 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc. · Feb 2007
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
K043203 · Wilson-Cook Medical, Inc. · May 2005
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
K043114 · Kimberly-Clark Corp. · Dec 2004
FASTRAC GASTRIC ACCESS PORT KIT
K033562 · C.R. Bard, Inc. · Dec 2003