Cleared Traditional

K933842 - KLEIN RECTAL TAMPNADE BALLOON

K933842 is the FDA 510(k) clearance for KLEIN RECTAL TAMPNADE BALLOON by Cook Urological, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K933842 · Cook Urological, Inc. · Gastroenterology & Urology device
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Sep 1994
Decision
419d
Days
Class 2
Risk

K933842 is an FDA 510(k) clearance for the KLEIN RECTAL TAMPNADE BALLOON. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 419 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K933842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1993
Decision Date September 29, 1994
Days to Decision 419 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
289d slower than avg
Panel avg: 130d · This submission: 419d
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 222
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K933842.
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · Abbott Laboratories · Mar 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · Abbott Laboratories · Jan 1995
VANSONNENBERG GASTROSTOMY CATHETER
K924850 · Boston Scientific Corp · Dec 1994
NON-BALLOON REPLACEMENT GASTROSTOMY KIT
K932295 · Biosearch Medical Products, Inc. · Sep 1994
BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
K935045 · Biosearch Medical Products, Inc. · Aug 1994
LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
K920579 · Wilson-Cook Medical, Inc. · Jul 1994