Cleared Traditional

K180983 - Maxcon Two Gallon Chemotherapy Container

K180983 is an FDA 510(k) clearance for Maxcon Two Gallon Chemotherapy Container, manufactured by Ningbo Maxcon Medical Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K180983 · Ningbo Maxcon Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
265d
Days
Class 2
Risk

K180983 is an FDA 510(k) clearance for the Maxcon Two Gallon Chemotherapy Container. 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 January 3, 2019 after a review of 265 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.

FDA 510(k) Submission Details - K180983

510(k) Number K180983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2018
Decision Date January 03, 2019
Days to Decision 265 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
136d slower than avg
Panel avg: 129d · This submission: 265d
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 94
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