Cleared Traditional

K931664 - SHARPS DISPOSABLE CONTAINERS

K931664 is an FDA 510(k) clearance for SHARPS DISPOSABLE CONTAINERS, 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 413-day FDA review.

K931664 · Bemis Mfg. Co. · General Hospital
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May 1994
Decision
413d
Days
Class 2
Risk

K931664 is an FDA 510(k) clearance for the SHARPS DISPOSABLE CONTAINERS. 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 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bemis Mfg. Co. devices

FDA 510(k) Submission Details - K931664

510(k) Number K931664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date May 23, 1994
Days to Decision 413 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
284d slower than avg
Panel avg: 129d · This submission: 413d
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 46
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K931664.
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
DISPOSAL PAD FOR SHARPS
K910516 · Visitec Co. · Apr 1991
QUALTEX NEEDLE COUNTERS
K903947 · Deroyal Industries, Inc. · Oct 1990