Cleared Traditional

Sharps container (K201523) - FDA 510(k) Clearance

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

K201523 · Zhejiang Gongdong Medical Technology Co., Ltd. · General Hospital
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Nov 2020
Decision
157d
Days
Class 2
Risk

K201523 is an FDA 510(k) clearance for the Sharps container. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Zhejiang Gongdong Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on November 12, 2020 after a review of 157 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 Zhejiang Gongdong Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K201523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2020
Decision Date November 12, 2020
Days to Decision 157 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 129d · This submission: 157d
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 Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Ivy Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MMK Container, Sharps

All 19
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K201523.
Promisemed Sharps container
K211890 · Promisemed Hangzhou Meditech Co., Ltd. · Nov 2021
Nitta M&T Safety Box
K211464 · Nitta M&T (Thailand) Co., Ltd. · Sep 2021
Tiger Reusable Sharps Container
K203305 · International Marketing Specialists, Inc. · Aug 2021
Tiger Sharps Containers
K190240 · International Marketing Specialists, Inc. · May 2019
OnSite Waste Sharps Container
K182235 · Bluestone Medical, Inc. · May 2019
Maxcon Two Gallon Chemotherapy Container
K180983 · Ningbo Maxcon Medical Technology Co., Ltd. · Jan 2019