510(k) Report

FDA applicant

Laboratorios Biogalenic S.A. DE C.V.

San Salvador, SV3 decisions2025–20260 recalls

FDA records 3 decisions for Laboratorios Biogalenic S.A. DE C.V. (San Salvador, SV) from 2025 to 2026: 3 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 161 days from receipt to decision, against 176 for FDA’s reviews in the same codes and years. Its devices cite 3 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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Laboratorios Biogalenic S.A. DE C.V.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 22026 (partial year): 1
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Laboratorios Biogalenic S.A. DE C.V. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2decisions
  • FRODressing, Wound, Drug1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 161 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 176 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2026
  • K243001Sterile Water USP and Sterile 0.9% Normal Saline USPLaboratorios Biogalenic S.A. DE C.V. · 2025
  • K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V. · 2025

All 3 as Laboratorios Biogalenic S.A. DE C.V. →

Other applicant names beginning “Laboratorios”

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

Laboratorios Grifols, S.A. 9