510(k) Report

FDA applicant

Cydar, Ltd.

Barrington, GB2 decisions2016–20210 recalls

FDA records 2 decisions for Cydar, Ltd. (Barrington, GB) from 2016 to 2021: 2 510(k) clearances. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 3 predicates, 1 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 Cydar, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 12021: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Cydar, Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cydar, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K160088Cydar EVCydar, Ltd. · 20163cite it
  • K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd. · 20211cites it

What has FDA decided for it lately?

  • K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd. · 2021
  • K160088Cydar EVCydar, Ltd. · 2016

All 2 as Cydar, Ltd. →