FDA applicant

Calypso Medical Technologies, Inc.

Seattle, WA5 decisions2006–20120 recalls

FDA records 5 decisions for Calypso Medical Technologies, Inc. (Seattle, WA) from 2006 to 2012: 5 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 19 predicates, 9 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, radiology panel, where it files most

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

FDA decisions per year

1in 2012

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Calypso Medical Technologies, 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?