510(k) Report

FDA applicant

Cascination AG

Bern, CH8 decisions2015–20260 recalls

FDA records 8 decisions for Cascination AG (Bern, CH) from 2015 to 2026: 8 510(k) clearances. Most are in product codes QQE (Image Management Software For Planning Of…) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 167 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 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 Cascination AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12016: 12021: 12022: 12024: 12025: 12026 (partial year): 2
2015high 2 (2026) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Cascination AG by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cascination 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?

  • QQEImage Management Software For Planning Of Otologic And Neurotologic Procedures4decisions
  • JAKSystem, X-Ray, Tomography, Computed3decisions
  • OEWTracking, Soft Tissue, Intraoperative1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 167 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K152473CAS-One IRCascination AG · 20162cite it
  • K203486OtoplanCascination AG · 20212cite it
  • K232022CAS-One IRCascination AG · 20241cites it

What has FDA decided for it lately?

  • K262080OtoplanCascination AG · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K242120OtoplanCascination AG · 2025
  • K232022CAS-One IRCascination AG · 2024
  • K220300OtoplanCascination AG · 2022
  • K203486OtoplanCascination AG · 2021
  • K152473CAS-One IRCascination AG · 2016
  • K143024CAS-One LiverCascination AG · 2015

All 8 as Cascination AG →