Cleared Traditional

K941664 - SHARP DISPOSAL CONTAINERS WALL SAFE

K941664 is an FDA 510(k) clearance for SHARP DISPOSAL CONTAINERS WALL SAFE, manufactured by Bemis Mfg. Co.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K941664 · Bemis Mfg. Co. · General Hospital
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May 1994
Decision
77d
Days
Class 2
Risk

K941664 is an FDA 510(k) clearance for the SHARP DISPOSAL CONTAINERS WALL SAFE. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Bemis Mfg. Co. (Sheboygan Falls, US). The FDA issued a Cleared decision on May 23, 1994 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K941664

510(k) Number K941664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date May 23, 1994
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
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 103
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K941664.
VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER
K943138 · Med-Safe Systems, Inc. · Nov 1994
IN-ROOM AND SHARPSTAR
K941991 · Sage Products, Inc. · Aug 1994
SHARPS DISPOSABLE CONTAINERS
K931664 · Bemis Mfg. Co. · May 1994
SHARPS DISPOSAL CONTAINER/PHLEBOTOMY
K941665 · Bemis Mfg. Co. · May 1994
OPERATING ROOM NEEDLE COUNTER
K923512 · Sharp-Trap, Inc. · Nov 1992
DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS
K915067 · American Medical Corp. · Mar 1992
K941664 · SHARP DISPOSAL CONTAINERS WALL SAFE
Download PDF Bemis Mfg. Co.