# K072982: Pari Hydrate V

- Pathway: 510(k) (Traditional)
- Applicant: Pari Innovative Manufacturers, Inc.
- Decided: Nov 29, 2007 after 37 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: 5 generations back to K913368 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033710: MR850 Respiratory Humidifier, Model MR850JHU, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K071707: PARI Hydrate G. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The PARI Hydrate V is intended to warm and add moisture to breathing gases to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases for administration to infant, pediatric, and adult patients. The Hydrate V is intended for use in homes, hospitals, and sub-acute institutions.

Source page: https://510kreport.com/device/K072982
Methodology: https://510kreport.com/methodology