Cleared Traditional

K942054 - SHARPS-TAINER

K942054 is an FDA 510(k) clearance for SHARPS-TAINER, manufactured by Winfield Industries. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K942054 · Winfield Industries · General Hospital
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Aug 1994
Decision
117d
Days
Class 2
Risk

K942054 is an FDA 510(k) clearance for the SHARPS-TAINER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Winfield Industries (San Diego, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Winfield Industries devices

FDA 510(k) Submission Details - K942054

510(k) Number K942054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date August 23, 1994
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 445
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K942054.
MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER
K943485 · Sherwood Medical Co. · Sep 1994
MONOJECT TRAY SIZE SHARPS CONTAINER
K943496 · Sherwood Medical Co. · Aug 1994
SHARPSAFE CAT NO. 4105, 4115 AND 4120
K942937 · Smiths Industries Medical Systems, Inc. · Aug 1994
MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER
K943578 · Sherwood Medical Co. · Aug 1994
BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS
K943594 · Baxter Healthcare Corp · Aug 1994
BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS
K943605 · Baxter Healthcare Corp · Aug 1994