FDA applicant

Lumen Biomedical, Inc.

Plymouth, MN5 decisions2006–20113 recalls

FDA records 5 decisions for Lumen Biomedical, Inc. (Plymouth, MN) from 2006 to 2011: 5 510(k) clearances. Most are in product codes NTE (Temporary Carotid Catheter For Embolic Capture) and QEZ (Aspiration Thrombectomy Catheter). Its devices cite 21 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

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 Lumen Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2014

2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lumen Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Lumen”

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

Lumen S.R.L. 1 Lumen Development and Manufacturing, Inc. 1

Lumen Biomedical, 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?

What has been recalled?

Other applicant names beginning “Lumen”