Cleared Traditional

K090559 - FOOTPRINT MEDICAL SILICONE FEEDING TUBE

K090559 is an FDA 510(k) clearance for FOOTPRINT MEDICAL SILICONE FEEDING TUBE, manufactured by Footprint Medical. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K090559 · Footprint Medical · Gastroenterology & Urology device
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May 2009
Decision
63d
Days
Class 2
Risk

K090559 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL SILICONE FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Footprint Medical (San Antonio, US). The FDA issued a Cleared decision on May 4, 2009 after a review of 63 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 Footprint Medical devices

FDA 510(k) Submission Details - K090559

510(k) Number K090559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date May 04, 2009
Days to Decision 63 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 130d · This submission: 63d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K090559.
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K091759 · Olympus Medical Systems Corporation · Sep 2009
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
K083153 · Hollister, Inc. · Feb 2009
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K081739 · Boston Scientific Corp · Dec 2008
ENTERAL ONLY EXTENSION SET
K082654 · Respironics, Inc. · Nov 2008