# K103316: Flowrest

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Feb 8, 2011 after 90 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: 7 generations back to K913368 (1992). 19 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092846: Airvo Series Humidifiers, Fisher & Paykel Healthcare, Ltd. (2010) Summary page 11.

## Most influential descendants
- K191010: Palladium High Flow Therapy System (2019), 2 descendants of its own
- K203357: HVT 2.0 (2021), 1 descendant of its own
- K254078: HVT 2.0 (2026), 0 descendants of its own

## Indications for use
The Flowrest® delivers warmed humidified high-flow breathing gases. The Flowrest® is intended for treating spontaneously breathing patients who require warmed and humidified high-flow respiratory gases within the homecare, sub-acute and hospital settings.

Source page: https://510kreport.com/device/K103316
Methodology: https://510kreport.com/methodology