Cleared Traditional

K943660 - PHLEBOTOMY SHARPS DISPOSAL CONTAINERS (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943660 · Sage Products, Inc. · General Hospital
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Mar 1995
Decision
238d
Days
Class 2
Risk

K943660 is an FDA 510(k) clearance for the PHLEBOTOMY SHARPS 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 K943660 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
110d slower than avg
Panel avg: 128d · 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 111
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K943660.
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222 · Zhejiang Gongdong Medical Technology Co., Ltd. · Dec 2025
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K251874 · Pureway Compliance, Inc. · Oct 2025
Community Containers (Flap and Daisy)
K252637 · Keter Canada, Inc. · Oct 2025
Promisemed Sharps container
K211890 · Promisemed Hangzhou Meditech Co., Ltd. · Nov 2021