Cleared Traditional

CATH CADDIE (K961884) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961884 · Mark-Clark · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
78d
Days
Class 2
Risk

K961884 is an FDA 510(k) clearance for the CATH CADDIE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Mark-Clark (Topka, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 78 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 Mark-Clark devices

Submission Details

510(k) Number K961884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1996
Decision Date August 01, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
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 123
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K961884.
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · Abbott Laboratories · Nov 1997
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · Abbott Laboratories · Oct 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375 · Boston Scientific Corp · Sep 1996
KANGAROO JEJUNAL FEEDING SYSTEM
K960677 · Sherwood Medical Co. · May 1996
KANGAROO FEEDING TUBE PLACMENT STYLET
K960632 · Sherwood Medical Co. · May 1996
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
K954429 · Sherwood Medical Co. · Mar 1996