510(k) Report

FDA applicant

Biogen

Cambridge, MA2 decisions2003–20040 recalls

FDA records 2 decisions for Biogen (Cambridge, MA) from 2003 to 2004: 2 510(k) clearances. Most are in product codes KZH (Introducer, Syringe Needle) and FMF (Syringe, Piston). Its devices cite 4 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 Biogen’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biogen since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KZHIntroducer, Syringe Needle1decision
  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K032425Invisiject Resusable Auto-InjectorBiogen · 20032cite it

What has FDA decided for it lately?

  • K042314Syringe Grip for the Avonex Pre-Filled SyringeBiogen · 2004
  • K032425Invisiject Resusable Auto-InjectorBiogen · 2003

All 2 as Biogen →