Cleared Traditional

K121105 - NUTRISAFE 2 FEEDING TUBE

K121105 is an FDA 510(k) clearance for NUTRISAFE 2 FEEDING TUBE, manufactured by Vygon Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K121105 · Vygon Corp. · Gastroenterology & Urology device
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Dec 2012
Decision
250d
Days
Class 2
Risk

K121105 is an FDA 510(k) clearance for the NUTRISAFE 2 FEEDING TUBE. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Vygon Corp. (Montgomeryville, US). The FDA issued a Cleared decision on December 18, 2012 after a review of 250 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 Vygon Corp. devices

FDA 510(k) Submission Details - K121105

510(k) Number K121105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2012
Decision Date December 18, 2012
Days to Decision 250 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 130d · This submission: 250d
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 K121105.
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
K180236 · Vr Medical Technology Co., Ltd. · Jan 2019
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
K131590 · Philips Medical Systems · Oct 2013
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
K120815 · Philips Medical Systems · Mar 2013
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