# K090915: Sterile Water for Inhalation Flex Bag, Usp

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Nov 18, 2009 after 231 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: 1 generation back to K760584 (1976). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780381: Respiratory Therapy Solutions - Flexible, Travenol Laboratories, S.A. (1978) Summary page 1.
- K853146: Respir Ther Humid Contain Sterile Water for Usp, Automatic Liquid Packaging, Inc. (1985) Summary page 1.
- K760584: U-Mid Prefilled Humidifier (500CC), Bd Becton Dickinson Vacutainer Systems Preanalytic (1976) Summary page 1.

## Most influential descendants
- K223551: Sterile Water for Inhalation in 1L Flexoval ® bottles. (2023), 1 descendant of its own
- K251419: Laboratorios Biogalenic Sterile Water for Inhalation, USP (2026), 0 descendants of its own
- K242717: Laboratorios Biogalenic Sterile Water for Inhalation, USP (2025), 0 descendants of its own

## Indications for use
The Sterile Water for Inhalation Flex Bag 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

Source page: https://510kreport.com/device/K090915
Methodology: https://510kreport.com/methodology