FDA applicant

Circadiance, LLC

Murrysville, PA5 decisions2009–20170 recalls

FDA records 5 decisions for Circadiance, LLC (Murrysville, PA) from 2009 to 2017: 5 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 5 predicates, 2 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 Circadiance, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Circadiance, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Circadiance, LLC’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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Circadiance, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?