510(k) Report

FDA applicant

Shenzhen Launch Electrical Co., Ltd.

Shenzhen, CN2 decisions2018–20250 recalls

FDA records 2 decisions for Shenzhen Launch Electrical Co., Ltd. (Shenzhen, CN) from 2018 to 2025: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and LDF (Electrode, Pacemaker, Temporary). Its devices cite 2 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 Shenzhen Launch Electrical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12025: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Shenzhen Launch Electrical Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FLLContinuous Measurement Thermometer1decision
  • LDFElectrode, Pacemaker, Temporary1decision

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K181967Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd. · 2025
  • K181967Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018

All 2 as Shenzhen Launch Electrical Co., Ltd. →