# K251419: Laboratorios Biogalenic Sterile Water for Inhalation, USP

- Pathway: 510(k) (Traditional)
- Applicant: Laboratorios Biogalenic S.A. DE C.V.
- Decided: Jan 14, 2026 after 252 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K760584 (1976). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090915: Sterile Water for Inhalation Flex Bag, Usp, Cardinal Health, Inc. (2009) Summary page 6.

## Indications for use
Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings. The intended patient population is Adults, Pediatrics, Infants and Neonates.

Source page: https://510kreport.com/device/K251419
Methodology: https://510kreport.com/methodology