FDA applicant

Dey Laboratories, Inc.

Concord, CA6 decisions1983–19970 recalls

FDA records 6 decisions for Dey Laboratories, Inc. (Concord, CA) from 1983 to 1997: 6 510(k) clearances. Most are in product codes CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 3 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Dey Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Dey Laboratories, 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?