Cleared Traditional

K944025 - SURGICAL INSTRUMENT TRAY

K944025 is an FDA 510(k) clearance for SURGICAL INSTRUMENT TRAY, manufactured by Riley Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K944025 · Riley Medical, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
97d
Days
Class 1
Risk

K944025 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Riley Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 97 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Riley Medical, Inc. devices

FDA 510(k) Submission Details - K944025

510(k) Number K944025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1994
Decision Date November 22, 1994
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
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 39
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K944025.
INSTRUMENT TRAY LINER
K971217 · General Hospital Supply Corp. · May 1997
SINGLE USE INSTRUMENT TRAY
K962328 · Medcare Medical Group, Inc. · Aug 1996
ARTHROSCOPY TRAY
K912106 · Medical Device Inspection Co., Inc. · Aug 1991
OPEN HEART TRAY
K912053 · Medical Device Inspection Co., Inc. · Aug 1991
HEART CATH TRAY
K912052 · Medical Device Inspection Co., Inc. · Aug 1991
MAJOR BASIN TRAY
K912104 · Medical Device Inspection Co., Inc. · Aug 1991