FDA applicant

Optiscan Biomedical Corporation

Hayward, CA2 decisions2017–20200 recalls

FDA records 2 decisions for Optiscan Biomedical Corporation (Hayward, CA) from 2017 to 2020: 2 510(k) clearances. All are in product code LZF (Pump, Infusion, Analytical Sampling). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Optiscan Biomedical Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Optiscan Biomedical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Optiscan Biomedical Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Optiscan Biomedical Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Optiscan”

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

Optiscan Pty., Ltd. 1

Optiscan Biomedical Corporation

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Optiscan”