510(k) Report

FDA applicant

Formosa-Cj Health Business Corp.

Mccordsville, IN1 decision1996–19960 recalls

FDA records 1 decision for Formosa-Cj Health Business Corp. (Mccordsville, IN) in 1996: 1 510(k) clearance. All are in product code CBP (Valve, Non-Rebreathing). 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 Formosa-Cj Health Business Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Formosa-Cj Health Business Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Formosa-Cj Health Business Corp. by year, 2007–2026Sources: 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

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.

  • K953230CPR Super Pocket PackFormosa-Cj Health Business Corp. · 19961cites it

What has FDA decided for it lately?

  • K953230CPR Super Pocket PackFormosa-Cj Health Business Corp. · 1996

The one decision as Formosa-Cj Health Business Corp. →

Other applicant names beginning “Formosa-Cj”

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

Formosa Medical Devices, Inc. 3Formosa Glove Industrial Co., Ltd. 3