510(k) Report

FDA applicant

Acare Technology Co., Ltd.

New Taipei City, TW2 decisions2011–20190 recalls

FDA records 2 decisions for Acare Technology Co., Ltd. (New Taipei City, TW) from 2011 to 2019: 2 510(k) clearances. Most are in product codes JCX (Apparatus, Suction, Ward Use, Portable…) and DQA (Oximeter). 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 and plastic surgery panel, where it files most

How often FDA has decided Acare Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2011: 12019: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Acare Technology Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Acare Technology 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?

  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision
  • DQAOximeter1decision

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.

  • K182950Acare Suction UnitAcare Technology Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K182950Acare Suction UnitAcare Technology Co., Ltd. · 2019
  • K111617Pulse Oximeter Model AB-F1/AH-S1/AH-M1Acare Technology Co., Ltd. · 2011

All 2 as Acare Technology Co., Ltd. →