# K223863: BONHAWA Respiratory Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Telesair, Inc.
- Decided: Oct 13, 2023 after 294 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: 9 generations back to K913368 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier, Fisher & Paykel Healthcare, Ltd. (2013) Summary page 5.

## Indications for use
The BONHAWA Respiratory Humidifier is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. It adds heat and moisture to the flow of gases. The flow may be from 2 to 70 L/min depending on the patient interface. The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.

Source page: https://510kreport.com/device/K223863
Methodology: https://510kreport.com/methodology