Cleared Traditional

K072831 - FROG

K072831 is an FDA 510(k) clearance for FROG, manufactured by Newby-Coombs, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 436-day FDA review.

K072831 · Newby-Coombs, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
436d
Days
Class 2
Risk

K072831 is an FDA 510(k) clearance for the FROG. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Newby-Coombs, LLC (Branchville, US). The FDA issued a Cleared decision on December 12, 2008 after a review of 436 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Newby-Coombs, LLC devices

FDA 510(k) Submission Details - K072831

510(k) Number K072831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2007
Decision Date December 12, 2008
Days to Decision 436 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
305d slower than avg
Panel avg: 131d · This submission: 436d
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 43
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K072831.
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
K083791 · 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
NEOMED POLYURETHANE FEEDING TUBE
K082238 · Neomed, Inc. · Oct 2008
NEOMED Enteral FEEDING TUBE
K072881 · Neomed, Inc. · Jan 2008
NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT
K071191 · Novartis Nutrition Corp. · Jul 2007