510(k) Report

FDA applicant

Changzhou Haili Medical Co., Ltd.

Changzhou, CN1 decision2023–20230 recalls

FDA records 1 decision for Changzhou Haili Medical Co., Ltd. (Changzhou, CN) in 2023: 1 510(k) clearance. All are in product code LQY (Locator, Root Apex). Its devices cite 1 predicate, 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

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

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Changzhou Haili Medical Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Changzhou Haili Medical Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LQYLocator, Root Apex1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. · 2023

The one decision as Changzhou Haili Medical Co., Ltd. →