510(k) Report

FDA applicant

Cas Innovations AG

Erlangen, DE2 decisions2008–20100 recalls

FDA records 2 decisions for Cas Innovations AG (Erlangen, DE) from 2008 to 2010: 2 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cas Innovations GmbH & Co. KG”.

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 Cas Innovations AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12010: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Cas Innovations AG by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cas Innovations AG’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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Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080624Navstationirad Emt, Version 1.1Cas Innovations AG · 20082cite it

What has FDA decided for it lately?

  • K093787Iguide CappaCas Innovations GmbH & Co. KG · 2010
  • K080624Navstationirad Emt, Version 1.1Cas Innovations AG · 2008

The one decision as Cas Innovations AG →The one decision as Cas Innovations GmbH & Co. KG →