Cleared Traditional

K982500 - CHAIT CECOSTOMY CATHETER

K982500 is the FDA 510(k) clearance for CHAIT CECOSTOMY CATHETER by Cook, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K982500 · Cook, Inc. · Gastroenterology & Urology device
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Jan 1999
Decision
191d
Days
Class 2
Risk

K982500 is an FDA 510(k) clearance for the CHAIT CECOSTOMY CATHETER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 27, 1999 after a review of 191 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

Submission Details

510(k) Number K982500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1998
Decision Date January 27, 1999
Days to Decision 191 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
61d slower than avg
Panel avg: 130d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K982500.
NUTRISAFE EXTENSION TUBE
K991918 · Vygon Corp. · Oct 1999
BARD BALLOON INFLATION SYSTEM
K991375 · C.R. Bard, Inc. · Sep 1999
TRIP TONOMETRY CATHETER, 8F
K992181 · Datex-Ohmeda, Inc. · Aug 1999
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203 · Rusch Intl. · Jun 1998
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)
K973892 · Rusch Intl. · May 1998
VYGON NEO-SUMP
K974806 · Vygon Corp. · Mar 1998