510(k) Report

FDA applicant

Grifols

East Stroudsburg, PA1 decision2011–20110 recalls

FDA records 1 decision for Grifols (East Stroudsburg, PA) in 2011: 1 510(k) clearance. All are in product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A…). 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, immunology panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Grifols by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)1decision

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.

  • K103757Immunofixation Electrophoresis Test Using Interlab G26 InstrumentGrifols · 20111cites it

What has FDA decided for it lately?

  • K103757Immunofixation Electrophoresis Test Using Interlab G26 InstrumentGrifols · 2011

The one decision as Grifols →

Other applicant names beginning “Grifols”

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

Grifols USA, LLC 3