Cleared Traditional

K100700 - MED-RX PEDIATRIC FEEDING TUBES AND ACCE...

K100700 is an FDA 510(k) clearance for MED-RX PEDIATRIC FEEDING TUBES AND ACCE..., manufactured by Benlan, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K100700 · Benlan, Inc. · Gastroenterology & Urology device
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Dec 2010
Decision
276d
Days
Class 2
Risk

K100700 is an FDA 510(k) clearance for the MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Benlan, Inc. (Oakville, CA). The FDA issued a Cleared decision on December 13, 2010 after a review of 276 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 Benlan, Inc. devices

FDA 510(k) Submission Details - K100700

510(k) Number K100700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2010
Decision Date December 13, 2010
Days to Decision 276 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
146d slower than avg
Panel avg: 130d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPD Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K100700.
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