Cleared Traditional

K922567 - LOW PROFILE CATHETER

K922567 is an FDA 510(k) clearance for LOW PROFILE CATHETER, manufactured by Rusch, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 1268-day FDA review.

K922567 · Rusch, Inc. · Gastroenterology & Urology device
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Nov 1995
Decision
1268d
Days
Class 2
Risk

K922567 is an FDA 510(k) clearance for the LOW PROFILE CATHETER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 1268 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 Rusch, Inc. devices

FDA 510(k) Submission Details - K922567

510(k) Number K922567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 01, 1992
Decision Date November 21, 1995
Days to Decision 1268 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1138d slower than avg
Panel avg: 130d · This submission: 1268d
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 346
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K922567.
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
K954429 · Sherwood Medical Co. · Mar 1996
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY
K954776 · United States Endoscopy Group, Inc. · Jan 1996
BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
K946249 · C.R. Bard, Inc. · Dec 1995
GASTROINTESTINAL TUBES & ACCESSORIES
K945618 · Applied Medical Technologies · Oct 1995
ENDOLUMINAL ACCESS TUBE
K941228 · Med Institute, Inc. · Sep 1995
PRG BUTTON
K946140 · Applied Medical Technologies · Aug 1995