Cleared Traditional

K922051 - KIT PAK'S FLUSHING KIT (FDA 510(k) Clearance)

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

K922051 · Kit Pak, Inc. · Gastroenterology & Urology device
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Jun 1993
Decision
412d
Days
Class 2
Risk

K922051 is an FDA 510(k) clearance for the KIT PAK'S FLUSHING KIT. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on June 17, 1993 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Kit Pak, Inc. devices

Submission Details

510(k) Number K922051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 01, 1992
Decision Date June 17, 1993
Days to Decision 412 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 130d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 237
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