Cleared Traditional

K082042 - GONGDONG DISPOSABLE SHARP CONTAINER

K082042 is an FDA 510(k) clearance for GONGDONG DISPOSABLE SHARP CONTAINER, manufactured by Zhejiang Gongdong Medical Plastic Factory. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K082042 · Zhejiang Gongdong Medical Plastic Factory · General Hospital
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Sep 2008
Decision
47d
Days
Class 2
Risk

K082042 is an FDA 510(k) clearance for the GONGDONG DISPOSABLE SHARP CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Zhejiang Gongdong Medical Plastic Factory (Huangyan, Taizhou, Zhejiang, CN). The FDA issued a Cleared decision on September 3, 2008 after a review of 47 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K082042

510(k) Number K082042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2008
Decision Date September 03, 2008
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 104
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K082042.
ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M
K090157 · Wcm Waste & Compliance Management, Inc. · May 2009
ENVIRO SHARP SOLUTIONS 3
K083511 · Industrial Water Solutions, Inc. · Mar 2009
SHARPS COMPLIANCE CONTAINER
K083129 · Sharps Compliance, Inc. · Dec 2008
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
K081821 · Global Pathogen Solutions, Inc. · Sep 2008
SHARPS TRANSPORT TUBE, MODEL 50035
K073577 · Sharps Compliance, Inc. · Jun 2008
ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
K081449 · Ultimed, Inc. · Jun 2008
K082042 · GONGDONG DISPOSABLE SHARP CONTAINER
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