Cleared Traditional

K922730 - LAKE OSTOMY CARE SET (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K922730 · Lake Medical Products, Inc. · Gastroenterology & Urology device
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Dec 1993
Decision
573d
Days
Class 1
Risk

K922730 is an FDA 510(k) clearance for the LAKE OSTOMY CARE SET. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 30, 1993 after a review of 573 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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 Lake Medical Products, Inc. devices

Submission Details

510(k) Number K922730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 05, 1992
Decision Date December 30, 1993
Days to Decision 573 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
443d slower than avg
Panel avg: 130d · This submission: 573d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.