# K042245: Vapotherm Model#2000I, 200H

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Aug 30, 2004 after 11 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: 2 generations back to K000401 (2000). 4 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 11 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) Summary page 1.
- K013486: Vapotherm 2000H, Vapotherm, Inc. (2003) Summary page 1.
- K040862: Guardian Neonate Cpap/Humidification System, Caradyne, Ltd. (2004) Summary page 1.

## Most influential descendants
- 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
- K070056: Vapotherm  Model# 2000I and 2000H (2007), 0 descendants of its own

## Indications for use
The Vapotherm 2000h and 2000i are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments of use - Home, Hospital, Sub-acute Institutions

Source page: https://510kreport.com/device/K042245
Methodology: https://510kreport.com/methodology