FDA applicant

Equidyne Systems, Inc.

San Diego, CA5 decisions1995–20020 recalls

FDA records 5 decisions for Equidyne Systems, Inc. (San Diego, CA) from 1995 to 2002: 5 510(k) clearances. All are in product code KZE (Injector, Fluid, Non-Electrically Powered). Its devices cite 2 predicates, 1 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Equidyne Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Equidyne Systems, 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?