FDA applicant

Laboratorios Grifols, S.A.

Parets Del Valles, Barcelona, ES9 decisions2003–20171 recall

FDA records 9 decisions for Laboratorios Grifols, S.A. (Parets Del Valles, Barcelona, ES) from 2003 to 2017: 9 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and KPE (Container, I.V.). Its devices cite 12 predicates, 7 of them its own earlier devices. 1 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 Laboratorios Grifols, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Laboratorios Grifols, S.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Laboratorios”

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

Laboratorios Biogalenic S.A. DE C.V. 3

Laboratorios Grifols, S.A.

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 “Laboratorios”