# K013486: Vapotherm 2000H

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: May 30, 2003 after 588 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: 1 generation back to K000401 (2000). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000401: Vapotherm, Model 2000I, Vapotherm, Inc. (2000)

## Most influential descendants
- K042245: Vapotherm Model#2000I, 200H (2004), 6 descendants of its own
- K072845: Precision Flow (2008), 2 descendants of its own
- K254078: HVT 2.0 (2026), 0 descendants of its own
- K193411: O2asis Personal Oxygen Humidifier (2020), 0 descendants of its own
- K111640: Precision Flow (R) - Heliox (2011), 0 descendants of its own

## Indications for use
The Vapotherm 2000h (5000) can mix air with oxygen from an external source and adds heat and moisture to the gas. The Vapotherm 2000h (5000) is for use in home, hospital or sub-acute institutional settings.

Source page: https://510kreport.com/device/K013486
Methodology: https://510kreport.com/methodology