Cleared Traditional

K112863 - ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN

K112863 is an FDA 510(k) clearance for ENTERAL ADMINISTRATION SET WITH SOLUTIO..., manufactured by Acta Medical, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K112863 · Acta Medical, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
181d
Days
Class 2
Risk

K112863 is an FDA 510(k) clearance for the ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SE.... Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Acta Medical, LLC (Plano, US). The FDA issued a Cleared decision on March 29, 2012 after a review of 181 days - an extended review 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: 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 Acta Medical, LLC devices

FDA 510(k) Submission Details - K112863

510(k) Number K112863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date March 29, 2012
Days to Decision 181 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
50d slower than avg
Panel avg: 131d · This submission: 181d
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 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K112863.
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NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
K120182 · Neomed, Inc. · Apr 2012
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
K112268 · Codan US Corp. · Mar 2012
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
K120272 · Kentec Medical, Inc. · Feb 2012
CORTRAK ENTERAL ACCESS DEVICE
K113351 · Corpak Medsystems · Jan 2012