FDA applicant

Chiron Vision Corp.

Irvine, CA34 decisions1980–19971 recall

FDA records 34 decisions for Chiron Vision Corp. (Irvine, CA) from 1980 to 1997: 34 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and EKX (Handpiece, Direct Drive, Ac-Powered). Its devices cite 3 predicates, 0 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Chiron Vision Corp. since 2007.

Recalls per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Chiron Vision Corp.’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 “Chiron”

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

Chiron Diagnostics Corp. 20 Chiron Ophthalmics 11 Chiron Intraoptics 4 Chiron Corp. 2

Chiron Vision 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?

What has been recalled?

Other applicant names beginning “Chiron”