Cleared Traditional

K861427 - ENTUBE TM

K861427 is an FDA 510(k) clearance for ENTUBE TM, manufactured by Entech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K861427 · Entech, Inc. · Gastroenterology & Urology device
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Jul 1986
Decision
93d
Days
Class 2
Risk

K861427 is an FDA 510(k) clearance for the ENTUBE TM, ENTERAL FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Entech, Inc. (Lebanon, US). The FDA issued a Cleared decision on July 18, 1986 after a review of 93 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 Entech, Inc. devices

FDA 510(k) Submission Details - K861427

510(k) Number K861427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1986
Decision Date July 18, 1986
Days to Decision 93 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 130d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K861427.
CRAIG NASO-GASTRIC TUBE HOLDER
K862855 · Henley Intl. · Nov 1986
T-FASTENER
K861599 · Medi-Tech, Inc. · Oct 1986
HOLLISTER DRAIN TUBE ATTACHMENT
K862573 · Hollister, Inc. · Sep 1986
TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
K861618 · Travenol Laboratories, S.A. · Jul 1986
ONE TIME ENTERAL FEEDING BAG
K860818 · Acme United Corp. · May 1986
SCLEROTHERAPY INJECTION CATHETER
K860991 · Endovations · May 1986