510(k) Report

FDA applicant

Changzhou Endoclean Medical Device Co., Ltd.

Changzhou, CN3 decisions2022–20230 recalls

FDA records 3 decisions for Changzhou Endoclean Medical Device Co., Ltd. (Changzhou, CN) from 2022 to 2023: 3 510(k) clearances. Most are in product codes ODC (Endoscope Channel Accessory) and OCX (Endoscopic Irrigation/Suction System). Since 2016 its 510(k)s took a median of 126 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 5 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, gastroenterology and urology panel, where it files most

How often FDA has decided Changzhou Endoclean Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 22023: 1
2022high 2 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Changzhou Endoclean Medical Device Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ODCEndoscope Channel Accessory2decisions
  • OCXEndoscopic Irrigation/Suction System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 126 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 118 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd. · 2023
  • K221310Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source TubingChangzhou Endoclean Medical Device Co., Ltd. · 2022
  • K221331Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd. · 2022

All 3 as Changzhou Endoclean Medical Device Co., Ltd. →