# K070107: Pari Hydrate G

- Pathway: 510(k) (Traditional)
- Applicant: Pari Innovative Manufacturers, Inc.
- Decided: Feb 23, 2007 after 43 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: 3 generations back to K000401 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042245: Vapotherm Model#2000I, 200H, Vapotherm, Inc. (2004) Summary page 1.
- K050314: Aquinox, Smiths Medical Asd, Inc. (2005) Summary page 1.

## Indications for use
The PARI Hydrate G is designed to warm and add moisture to breathing gases for administration to infant, pediatric; and adult patients. The Hydrate G is intended for use in homes, hospitals, and sub-acute institutions.

Source page: https://510kreport.com/device/K070107
Methodology: https://510kreport.com/methodology