Cleared Traditional

K962328 - SINGLE USE INSTRUMENT TRAY

K962328 is an FDA 510(k) clearance for SINGLE USE INSTRUMENT TRAY, manufactured by Medcare Medical Group, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K962328 · Medcare Medical Group, Inc. · General & Plastic Surgery device
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Aug 1996
Decision
64d
Days
Class 1
Risk

K962328 is an FDA 510(k) clearance for the SINGLE USE INSTRUMENT TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on August 9, 1996 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medcare Medical Group, Inc. devices

FDA 510(k) Submission Details - K962328

510(k) Number K962328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1996
Decision Date August 09, 1996
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
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 - FSM Tray, Surgical, Instrument

All 38
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K962328.
INSTRUMENT TRAY LINER
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