510(k) Report

FDA applicant

Ashitaka Factory of Terumo Corp.

Fujinomiya Shizuoka, JP6 decisions2013–20210 recalls

FDA records 6 decisions for Ashitaka Factory of Terumo Corp. (Fujinomiya Shizuoka, JP) from 2013 to 2021: 6 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ashitaka Factory of Terumo Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ashitaka Factory of Terumo Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2013: 12015: 22016: 12017: 12021: 1
2013high 2 (2015) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Ashitaka Factory of Terumo Corp. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ashitaka Factory of Terumo Corp.’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?

  • DQOCatheter, Intravascular, Diagnostic2decisions
  • DQYCatheter, Percutaneous2decisions
  • DQXWire, Guide, Catheter1decision
  • DTZOxygenator, Cardiopulmonary Bypass1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 133 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 117 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 0 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.

  • K152740Radifocus GlidewireAshitaka Factory of Terumo Corp. · 20155cite it
  • K150232Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp. · 20151cites it
  • K170223ProgreatAshitaka Factory of Terumo Corporation · 20171cites it
  • K130520Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 20131cites it

What has FDA decided for it lately?

  • K203521FineCross M3Ashitaka Factory of Terumo Corporation · 2021
  • K170223ProgreatAshitaka Factory of Terumo Corporation · 2017
  • K161546R2P SlenGuideAshitaka Factory of Terumo Corporation · 2016
  • K152740Radifocus GlidewireAshitaka Factory of Terumo Corp. · 2015
  • K150232Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp. · 2015
  • K130520Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp. · 2013

All 3 as Ashitaka Factory of Terumo Corp. →All 3 as Ashitaka Factory of Terumo Corporation →

Other applicant names beginning “Ashitaka”

FDA records each applicant name separately; these may or may not be the same firm.

Ashitaka Factory of Terumo Coporation 1