Cleared Traditional

K943658 - CHEMOTHERAPY WASTE DISPOSAL CONTAINERS

K943658 is an FDA 510(k) clearance for CHEMOTHERAPY WASTE DISPOSAL CONTAINERS, manufactured by Sage Products, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K943658

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
Combination Product No
PCCP Authorized No
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.

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 72
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K943658.
BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
K964858 · Bemis Mfg. Co. · Feb 1997
SHARPS SAFE 1.5 & SHARPS SAFE 2.0
K955514 · Dura-Vac Products · Aug 1996
BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)
K960525 · Bemis Mfg. Co. · Mar 1996
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