FDA applicant

Sensidyne, Inc.

Clearwater, FL4 decisions2000–20020 recalls

FDA records 4 decisions for Sensidyne, Inc. (Clearwater, FL) from 2000 to 2002: 4 510(k) clearances. Most are in product codes DQA (Oximeter) and CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). Its devices cite 1 predicate, 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Sensidyne, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Sensidyne, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?