Cleared Traditional

K222905 - Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) (FDA 510(k) Clearance)

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

K222905 · Ningbo Maxcon Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
251d
Days
Class 2
Risk

K222905 is an FDA 510(k) clearance for the Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Contai.... Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Ningbo Maxcon Medical Technology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on June 1, 2023 after a review of 251 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 Ningbo Maxcon Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K222905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2022
Decision Date June 01, 2023
Days to Decision 251 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
123d slower than avg
Panel avg: 128d · This submission: 251d
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

Shenglin (Hangzhou) Consultants, Inc.
Henry Zhang

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 111
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K222905.
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
PureWay 1.4 Quart Sharps Collector
K231484 · Pureway Compliance, Inc. · Sep 2023
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K222906 · Ningbo Maxcon Medical Technology Co., Ltd. · Jun 2023
Qlicksmart BladeFlask UNIVERSAL
K213274 · Qlicksmart Pty , Ltd. · Jun 2022