FDA applicant

Bionix Development Corp.

Toledo, OH13 decisions1990–20180 recalls

FDA records 13 decisions for Bionix Development Corp. (Toledo, OH) from 1990 to 2018: 13 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 22 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bionix Development Corporation”.

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

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Bionix Development Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bionix Development Corp.’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 “Bionix”

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

Bionix Corp. 2

Bionix Development Corp.

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 “Bionix”