Cleared Traditional

K823438 - HANDI-TRAY

K823438 is the FDA 510(k) clearance for HANDI-TRAY by Treace Medical, Inc.. It is a Class 1 General & Plastic Surgery device (product code FSM) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K823438 · Treace Medical, Inc. · General & Plastic Surgery device
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Jan 1983
Decision
59d
Days
Class 1
Risk

K823438 is an FDA 510(k) clearance for the HANDI-TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Treace Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 59 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 Treace Medical, Inc. devices

Submission Details

510(k) Number K823438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1982
Decision Date January 14, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
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

All 20
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K823438.
STERILE LACERATION TRAY CAT. #749
K900479 · Busse Hospital Disposables, Inc. · Feb 1990
STERILIZATION TRAY, TMJ INSTRUMENT SET
K871924 · Arthropedics, Inc. · Jun 1987
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
K870892 · Medsurg Industries, Inc. · Apr 1987
OPERATING ROOM KIT
K811916 · American Hospital Supply Corp. · Oct 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC
K802964 · Associated Medical Products Co. · Jan 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418
K802965 · Associated Medical Products Co. · Jan 1981