510(k) Report

FDA applicant

Terumo Bct

Lakewood, CO1 decision2015–20150 recalls

FDA records 1 decision for Terumo Bct (Lakewood, CO) in 2015: 1 510(k) clearance. All are in product code LKN (Separator, Automated, Blood Cell And Plasma…). Its devices cite 2 predicates, 0 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

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

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

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

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Which product codes does it file in?

  • LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection…Terumo Bct · 20151cites it

What has FDA decided for it lately?

  • K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection…Terumo Bct · 2015

The one decision as Terumo Bct →

Other applicant names beginning “Terumo”

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

Terumo Medical Corp. 160Terumo Cardiovascular Systems Corp. 74Terumo Corp. 34Terumo America, Inc. 31Terumo Europe N.V. 28Terumo (Philippines) Corporation 5Terumo Medical Products (Hangzhou) Co., Ltd. 5Terumo Medical Coporation 1Terumo Cardiovascular Systems Thi Plant 1Terumo Clinical Supply Co., Ltd. 1