Cleared Traditional

SINGLE USE INSTRUMENT TRAY (K962328) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K962328 · Medcare Medical Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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

Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K962328.
MICRO CLIP STERILIZING CASE #65199
K801470 · Edward Weck, Inc. · Jul 1980
MICRESURGICAL TRAY, SM.,MED., & LG.
K800367 · Edward Weck, Inc. · Mar 1980
WECK RACK (STERILIZING ACCESSORY TRAY)
K791743 · Edward Weck, Inc. · Sep 1979
ARMOR-KOT SURGICAL INSTRUMENTS
K771680 · Storz Instrument Co. · Nov 1977
INSTRUMENTS, GENERAL HAND & SURGERY
K760311 · Depuy, Inc. · Aug 1976