FDA applicant

Dana Laboratories

Costa Mesa, CA2 decisions1985–19868 recalls

FDA records 2 decisions for Dana Laboratories (Costa Mesa, CA) from 1985 to 1986: 2 510(k) clearances. Most are in product codes KPO (Dialysate Concentrate For Hemodialysis (Liquid…) and FKQ (System, Dialysate Delivery, Central Multiple…). 8 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Dana Laboratories since 2007.

Recalls per year

6in 2025

2007high 6 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Dana”

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

Dana Products, Inc. 9

Dana Laboratories

Which product codes does it file in?

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 “Dana”