Cleared Traditional

K100526 - AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE

K100526 is the FDA 510(k) clearance for AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE by Kentec Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FPD) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K100526 · Kentec Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
57d
Days
Class 2
Risk

K100526 is an FDA 510(k) clearance for the AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Kentec Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on April 22, 2010 after a review of 57 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 Kentec Medical, Inc. devices

Submission Details

510(k) Number K100526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2010
Decision Date April 22, 2010
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPD Tube, Feeding
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 - FPD Tube, Feeding

All 18
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K100526.
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
K120815 · Philips Medical Systems · Mar 2013
NUTRISAFE 2 FEEDING TUBE
K121105 · Vygon Corp. · Dec 2012
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
K100163 · Vygon Corp. · Oct 2011
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp · Jun 2009
NUTRISAFE 2
K060944 · Vygon Corp. · Sep 2006
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · Vygon Corp. · Jan 2002