# K222351: inspired™ VHB20 Heated Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Vincent Healthcare Products Limited
- Decided: Dec 21, 2022 after 139 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: 6 generations back to K913368 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073706: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 4.

## Indications for use
The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases. The inspired™ VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.

Source page: https://510kreport.com/device/K222351
Methodology: https://510kreport.com/methodology