510(k) Report

FDA applicant

Dongguan Simzo Electronic Technology Co., Ltd.

Dongguan City, CN3 decisions2018–20230 recalls

FDA records 3 decisions for Dongguan Simzo Electronic Technology Co., Ltd. (Dongguan City, CN) from 2018 to 2023: 3 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and CAF (Nebulizer (Direct Patient Interface)). Since 2016 its 510(k)s took a median of 287 days from receipt to decision, against 218 for FDA’s reviews in the same codes and years. 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 Dongguan Simzo Electronic Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018: 12021: 12023: 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 — Dongguan Simzo Electronic Technology 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 Thermometer2decisions
  • CAFNebulizer (Direct Patient Interface)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 287 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 218 days; 1 of its 3 were faster than that.

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 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.

  • K173048No-contact Forehead ThermometerDongguan Simzo Electronic Technology Co., Ltd. · 20182cite it
  • K230379Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K230379Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd. · 2023
  • K211583Infrared Thermometer, Model: HW-1Dongguan Simzo Electronic Technology Co., Ltd. · 2021
  • K173048No-contact Forehead ThermometerDongguan Simzo Electronic Technology Co., Ltd. · 2018

All 3 as Dongguan Simzo Electronic Technology Co., Ltd. →