# K853146: Respir Ther Humid Contain Sterile Water for Usp

- Pathway: 510(k) (Traditional)
- Applicant: Automatic Liquid Packaging, Inc.
- Decided: Aug 6, 1985 after 8 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090915: Sterile Water for Inhalation Flex Bag, Usp (2009), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K853146
Methodology: https://510kreport.com/methodology