Cleared Special

K992494 - FLEXIFLO ENTERAL FEEDING TUBE

K992494 is an FDA 510(k) clearance for FLEXIFLO ENTERAL FEEDING TUBE, manufactured by Ross Product Div. Abbott Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Special 510(k) pathway after a 30-day FDA review.

K992494 · Ross Product Div. Abbott Laboratories · Gastroenterology & Urology device
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Aug 1999
Decision
30d
Days
Class 2
Risk

K992494 is an FDA 510(k) clearance for the FLEXIFLO ENTERAL FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Ross Product Div. Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on August 25, 1999 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ross Product Div. Abbott Laboratories devices

FDA 510(k) Submission Details - K992494

510(k) Number K992494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date August 25, 1999
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 347
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K992494.
NUTRISAFE EXTENSION TUBE
K991918 · Vygon Corp. · Oct 1999
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
K993138 · Ballard Medical Products · Oct 1999
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999
TRIP TONOMETRY CATHETER, 8F
K992181 · Datex-Ohmeda, Inc. · Aug 1999
CHAIT CECOSTOMY CATHETER
K982500 · Cook, Inc. · Jan 1999
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
K982894 · Ballard Medical Products · Sep 1998