510(k) Report

FDA applicant

Kofu Factory of Terumo Corp.

Elkton, MD4 decisions2005–20140 recalls

FDA records 4 decisions for Kofu Factory of Terumo Corp. (Elkton, MD) from 2005 to 2014: 4 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 10 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, general hospital panel, where it files most

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

FDA decisions per year

2in 2014

2012: 12014: 2
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kofu Factory of Terumo Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kofu 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.

See the 510(k) Report

Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions

Whose devices does it build on?

Its devices cite 10 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.

  • K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 20142cite it
  • K052561Terumo Micro Tapered Pen NeedleKofu Factory of Terumo Corp. · 20052cite it

What has FDA decided for it lately?

  • K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp. · 2014
  • K141138Surflash Safety I.V. CatheterKofu Factory of Terumo Corp. · 2014
  • K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp. · 2012
  • K052561Terumo Micro Tapered Pen NeedleKofu Factory of Terumo Corp. · 2005

All 4 as Kofu Factory of Terumo Corp. →