510(k) Report

FDA applicant

Ningbo Maxcon Medical Technology Co., Ltd.

Ningbo, CN4 decisions2019–20230 recalls

FDA records 4 decisions for Ningbo Maxcon Medical Technology Co., Ltd. (Ningbo, CN) from 2019 to 2023: 4 510(k) clearances. All are in product code MMK (Container, Sharps). Since 2016 its 510(k)s took a median of 265 days from receipt to decision, against 258 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Ningbo Maxcon Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2019: 22023: 2
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Ningbo Maxcon Medical Technology Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MMKContainer, Sharps4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 265 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 258 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 20192cite it
  • K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container…Ningbo Maxcon Medical Technology Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K222906Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421Ningbo Maxcon Medical Technology Co., Ltd. · 2023
  • K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container…Ningbo Maxcon Medical Technology Co., Ltd. · 2023
  • K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019
  • K180983Maxcon Two Gallon Chemotherapy ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019

All 4 as Ningbo Maxcon Medical Technology Co., Ltd. →