FDA applicant

Focus Technologies, Inc.

Cypress, CA5 decisions2002–20041 recall

FDA records 5 decisions for Focus Technologies, Inc. (Cypress, CA) from 2002 to 2004: 5 510(k) clearances. Most are in product codes NOP (Elisa, Antibody, West Nile Virus) and MXJ (Enzyme Linked Immunosorbent Assay, Herpes…). Its devices cite 6 predicates, 1 of them its own earlier devices. 1 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, microbiology panel, where it files most

How often FDA has decided Focus Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Focus Technologies, Inc. since 2007.

Recalls per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Focus Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Focus Technologies, Inc.’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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Other applicant names beginning “Focus”

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

Focus Diagnostics, Inc. 18 Focus Medical, LLC 10 Focus International, Inc. 1 Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC 1 Focus Surgery, Inc. 1

Focus Technologies, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Focus”