Cleared Traditional

HOSPITAL KIT GP 103 (K922127) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K922127 · Savoy Medical Supply Co., Inc. · General & Plastic Surgery device
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Mar 1993
Decision
327d
Days
Class 1
Risk

K922127 is an FDA 510(k) clearance for the HOSPITAL KIT GP 103. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Savoy Medical Supply Co., Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 29, 1993 after a review of 327 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 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. 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 Savoy Medical Supply Co., Inc. devices

Submission Details

510(k) Number K922127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received May 06, 1992
Decision Date March 29, 1993
Days to Decision 327 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
212d slower than avg
Panel avg: 115d · This submission: 327d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDM Instrument, Manual, Surgical, General Use
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.