Cleared Traditional

K942902 - SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER

K942902 is an FDA 510(k) clearance for SHARPS-TAINER SMALL OPENING W/NEEDLE RE..., manufactured by Winfield Co., Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K942902 · Winfield Co., Inc. · General Hospital
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Dec 1994
Decision
231d
Days
Class 2
Risk

K942902 is an FDA 510(k) clearance for the SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Winfield Co., Inc. (Brentwood, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 231 days - an extended review cycle.

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 Co., Inc. devices

FDA 510(k) Submission Details - K942902

510(k) Number K942902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date December 15, 1994
Days to Decision 231 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
102d slower than avg
Panel avg: 129d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
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 - MMK Container, Sharps

All 86
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K942902.
CHEMOTHERAPY WASTE DISPOSAL CONTAINERS
K943658 · Sage Products, Inc. · Mar 1995
ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS
K943659 · Sage Products, Inc. · Mar 1995
PHLEBOTOMY SHARPS DISPOSAL CONTAINERS
K943660 · Sage Products, Inc. · Mar 1995
THE SHARPS COLLECTION AND DISPOSAL SYSTEM
K945197 · Devon Industries, Inc. · Dec 1994
IN-ROOM AND SHARPSTAR
K941991 · Sage Products, Inc. · Aug 1994
ICAN NEEDLE COUNTERS
K913446 · Icn Pharmaceuticals, Inc. · Sep 1991