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510(k) K251419

Laboratorios Biogalenic Sterile Water for Inhalation, USP by Laboratorios Biogalenic S.A. DE C.V. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2026
Date Received
May 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Laboratorios Biogalenic S.A. DE C.V.

  • K243001 — Sterile Water USP and Sterile 0.9% Normal Saline USP (March 6, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)

Other clearances for product code BTT

  • K251448 — FL-10000U Respiratory Humidifier (January 16, 2026)
  • K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (December 19, 2025)
  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)
  • K233821 — F&P Optiflow Oxygen Kit (AA451J) (June 13, 2024)