Cleared Traditional

STERILE SURGICAL INSTRUMENT TRAYS (K925215) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K925215 · American Healthcare Supply Co., Inc. · General & Plastic Surgery device
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Jun 1993
Decision
228d
Days
Class 1
Risk

K925215 is an FDA 510(k) clearance for the STERILE SURGICAL INSTRUMENT TRAYS. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by American Healthcare Supply Co., Inc. (South Plainfield, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 228 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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. Standard predicate reliance. 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 American Healthcare Supply Co., Inc. devices

Submission Details

510(k) Number K925215 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 16, 1992
Decision Date June 01, 1993
Days to Decision 228 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
113d slower than avg
Panel avg: 115d · This submission: 228d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.