FDA applicant

Terumobct, Inc.

Lakewood, CO8 decisions2013–20190 recalls

FDA records 8 decisions for Terumobct, Inc. (Lakewood, CO) from 2013 to 2019: 8 510(k) clearances. Most are in product codes LKN (Separator, Automated, Blood Cell And Plasma…) and KCY (Tourniquet, Pneumatic). Its devices cite 9 predicates, 3 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 and plastic surgery panel, where it files most

How often FDA has decided Terumobct, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Terumobct, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Terumobct, Inc.’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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Terumobct, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?