Cleared Traditional

K923905 - WOUND DRESSING KIT (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923905 · Kit Pak, Inc. · General & Plastic Surgery device
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Jul 1993
Decision
332d
Days
Class 2
Risk

K923905 is an FDA 510(k) clearance for the WOUND DRESSING KIT. Classified as Wound Dressing Kit (product code MCY), Class II - Special Controls.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5075 - the FDA general and plastic surgery 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kit Pak, Inc. devices

Submission Details

510(k) Number K923905 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 04, 1992
Decision Date July 02, 1993
Days to Decision 332 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 114d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MCY Wound Dressing Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5075
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 General & Plastic Surgery devices follow this clearance model.