# K223551: Sterile Water for Inhalation in 1L Flexoval ® bottles.

- Pathway: 510(k) (Traditional)
- Applicant: Hometa, Inc.
- Decided: Aug 3, 2023 after 251 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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 5.

## Most influential descendants
- K242717: Laboratorios Biogalenic Sterile Water for Inhalation, USP (2025), 0 descendants of its own

## Indications for use
The Sterile Water for Inhalation Flexoval® Bottle 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 by qualified staff. The Sterile Water for Inhalation is intended for use in all patient populations including adults, pediatrics, infants and neonates.

Source page: https://510kreport.com/device/K223551
Methodology: https://510kreport.com/methodology