# K070056: Vapotherm  Model# 2000I and 2000H

- Pathway: 510(k) (Special)
- Applicant: Vapotherm, Inc.
- Decided: Apr 13, 2007 after 98 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: 3 generations back to K000401 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042245: Vapotherm Model#2000I, 200H, Vapotherm, Inc. (2004) Summary page 2.
- (no number) Vapotherm 2000h: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K070056
Methodology: https://510kreport.com/methodology