Cleared Traditional

K943658 - CHEMOTHERAPY WASTE DISPOSAL CONTAINERS

K943658 is the FDA 510(k) clearance for CHEMOTHERAPY WASTE DISPOSAL CONTAINERS by Sage Products, Inc.. It is a Class 2 General Hospital device (product code MMK) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K943658 · Sage Products, Inc. · General Hospital
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Mar 1995
Decision
238d
Days
Class 2
Risk

K943658 is an FDA 510(k) clearance for the CHEMOTHERAPY WASTE DISPOSAL CONTAINERS. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 238 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 Sage Products, Inc. devices

Submission Details

510(k) Number K943658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1994
Decision Date March 22, 1995
Days to Decision 238 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
109d slower than avg
Panel avg: 129d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 34
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K943658.
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012
POINT OF USE II SHARPS-A-GATOR
K964387 · Graphic Controls Corp. · Mar 1997
THE SHARPS COLLECTION AND DISPOSAL SYSTEM
K945197 · Devon Industries, Inc. · Dec 1994
DISPOSAL PAD FOR SHARPS
K910516 · Visitec Co. · Apr 1991
QUALTEX NEEDLE COUNTERS
K903947 · Deroyal Industries, Inc. · Oct 1990