510(k) Report

FDA applicant

Circadian, Inc.

San Jose, CA13 decisions1980–19920 recalls

FDA records 13 decisions for Circadian, Inc. (San Jose, CA) from 1980 to 1992: 13 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DSI (Detector And Alarm, Arrhythmia). 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 Circadian, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Circadian, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Circadian, Inc.’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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