Cleared Traditional

K950017 - FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM

K950017 is an FDA 510(k) clearance for FLEXIFLO FLOCATOR SMALL BOWEL FEEDING S..., manufactured by Ross Products. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 801-day FDA review.

K950017 · Ross Products · Gastroenterology & Urology device
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Mar 1997
Decision
801d
Days
Class 2
Risk

K950017 is an FDA 510(k) clearance for the FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Ross Products (Columbus, US). The FDA issued a Cleared decision on March 14, 1997 after a review of 801 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 Ross Products devices

FDA 510(k) Submission Details - K950017

510(k) Number K950017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1995
Decision Date March 14, 1997
Days to Decision 801 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
670d slower than avg
Panel avg: 131d · This submission: 801d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K950017.
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT
K971230 · Innerdyne, Inc. · Jun 1997
#ES-32 SUCTION CATHETER 32 FR.
K970890 · Tri-Med Specialties, Inc. · May 1997
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)
K965087 · Sandoz Nutrition · Mar 1997
COMPAT NASOJEJUNAL FEEDING TUBE
K961664 · Sandoz Nutrition · Oct 1996
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · Abbott Laboratories · Oct 1996
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
K961345 · Applied Medical Technologies · Sep 1996