510(k) Report

FDA applicant

Firstar Healthcare Co., Ltd.

Dover, DE1 decision2010–20102 recalls

FDA records 1 decision for Firstar Healthcare Co., Ltd. (Dover, DE) in 2010: 1 510(k) clearance. All are in product code CBP (Valve, Non-Rebreathing). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Firstar Healthcare Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

2in 2016

2016: 2
2010high 2 (2016) · low 0 (2010)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • CBPValve, Non-Rebreathing1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K083418CPR MaskFirstar Healthcare Co., Ltd. · 20102 recalls

The one decision as Firstar Healthcare Co., Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K0834185195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.May 16, 2016Class II
  • K083418Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter.…May 16, 2016Class II

Other applicant names beginning “Firstar”

FDA records each applicant name separately; these may or may not be the same firm.

Firstar Dental Company 1Firstar Healthcare Company Limited (Guangzhou) 1