Cleared Traditional

K083791 - CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S

K083791 is an FDA 510(k) clearance for CORFLO ANTI IV ENTERAL FEEDING SET, manufactured by Corpak Medsystems. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K083791 · Corpak Medsystems · Gastroenterology & Urology device
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Mar 2009
Decision
75d
Days
Class 2
Risk

K083791 is an FDA 510(k) clearance for the CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Corpak Medsystems (Wheeling, US). The FDA issued a Cleared decision on March 4, 2009 after a review of 75 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 Corpak Medsystems devices

FDA 510(k) Submission Details - K083791

510(k) Number K083791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2008
Decision Date March 04, 2009
Days to Decision 75 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 131d · This submission: 75d
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 39
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K083791.
VR MEDICAL ENTERAL ORAL SYRINGE
K110853 · Vr Medical · May 2011
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp · Jun 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
K083776 · Corpak Medsystems · Mar 2009
CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB
K083786 · Corpak Medsystems · Feb 2009
CORFLO ANTI IV ENTERAL FEEDING TUBE
K083210 · Corpak Medsystems · Dec 2008
FROG
K072831 · Newby-Coombs, LLC · Dec 2008