510(k) Report

FDA applicant

Foshan Care Medical Technology Co., Ltd.

Carmichael, CA4 decisions2010–20240 recalls

FDA records 4 decisions for Foshan Care Medical Technology Co., Ltd. (Carmichael, CA) from 2010 to 2024: 4 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 3 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2024

2010: 12011: 12013: 12024: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Foshan Care Medical Technology Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Foshan Care Medical 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?

  • CAWGenerator, Oxygen, Portable2decisions
  • CAFNebulizer (Direct Patient Interface)1decision
  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K240840Oxygen Concentrator (ZY-10AB/115)Foshan Care Medical Technology Co., Ltd. · 20242cite it

What has FDA decided for it lately?

  • K240840Oxygen Concentrator (ZY-10AB/115)Foshan Care Medical Technology Co., Ltd. · 2024
  • K130001Care SU01A Suction AspiratorFoshan Care Medical Technology Co., Ltd. · 2013
  • K101552Foshan Care Medical Nebulizer Model KYWH2001Foshan Care Medical Technology Co., Ltd. · 2011
  • K102245Care ZY5BA Oxygen ConcentratorFoshan Care Medical Technology Co., Ltd. · 2010

All 4 as Foshan Care Medical Technology Co., Ltd. →