FDA applicant

Bionime Coporation

San Juan Capistrano, CA3 decisions2014–20150 recalls

FDA records 3 decisions for Bionime Coporation (San Juan Capistrano, CA) from 2014 to 2015: 3 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 9 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, clinical chemistry panel, where it files most

How often FDA has decided Bionime Coporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2014high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Bionime Coporation by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bionime Coporation’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 “Bionime”

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

Bionime Corporation 21

Bionime Coporation

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?

Other applicant names beginning “Bionime”