Cleared Traditional

K922128 - HOSPITAL KIT EP 104

K922128 is an FDA 510(k) clearance for HOSPITAL KIT EP 104, manufactured by Savoy Medical Supply Co., Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K922128 · Savoy Medical Supply Co., Inc. · General & Plastic Surgery device
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Mar 1993
Decision
321d
Days
Class 1
Risk

K922128 is an FDA 510(k) clearance for the HOSPITAL KIT EP 104. 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 23, 1993 after a review of 321 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

FDA 510(k) Submission Details - K922128

510(k) Number K922128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 06, 1992
Decision Date March 23, 1993
Days to Decision 321 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
206d slower than avg
Panel avg: 115d · This submission: 321d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

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.

Regulatory Peers - MDM Instrument, Manual, Surgical, General Use

All 14
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K922128.
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K911369 · Deroyal Industries, Inc. · May 1991