510(k) Report

FDA applicant

Shenling Medical Device Co., Ltd.

Los Angeles, CA1 decision2000–20000 recalls

FDA records 1 decision for Shenling Medical Device Co., Ltd. (Los Angeles, CA) in 2000: 1 510(k) clearance. All are in product code MQX (Needle, Acupuncture, Single Use). 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 Shenling Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shenling Medical Device Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shenling Medical Device Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQXNeedle, Acupuncture, Single Use1decision

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.

  • K002411Shenling Acupuncture NeedlesShenling Medical Device Co., Ltd. · 20001cites it

What has FDA decided for it lately?

  • K002411Shenling Acupuncture NeedlesShenling Medical Device Co., Ltd. · 2000

The one decision as Shenling Medical Device Co., Ltd. →