Cleared Traditional

K953797 - SHARPS DISPOSAL CONTAINERS

K953797 is an FDA 510(k) clearance for SHARPS DISPOSAL 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 108-day FDA review.

K953797 · Bemis Mfg. Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
108d
Days
Class 2
Risk

K953797 is an FDA 510(k) clearance for the SHARPS DISPOSAL 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 November 27, 1995 after a review of 108 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 Bemis Mfg. Co. devices

FDA 510(k) Submission Details - K953797

510(k) Number K953797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1995
Decision Date November 27, 1995
Days to Decision 108 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
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 K953797.
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
K980490 · Sage Products, Inc. · Feb 1998
POINT OF USE II SHARPS-A-GATOR
K964387 · Graphic Controls Corp. · Mar 1997
BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
K964858 · Bemis Mfg. Co. · Feb 1997
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