Cleared Traditional

SHARPS-TAINER (K942054) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 191
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K942054.
MONOJECT LUER ADAPTER
K940961 · Sherwood Medical Co. · Sep 1994
MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER
K943485 · Sherwood Medical Co. · Sep 1994
MONOJECT TRAY SIZE SHARPS CONTAINER
K943496 · Sherwood Medical Co. · 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