# K000401: Vapotherm, Model 2000I

- Pathway: 510(k) (Traditional)
- Applicant: Vapotherm, Inc.
- Decided: Aug 24, 2000 after 199 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
No predicates in its family tree.
11 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040862: Guardian Neonate Cpap/Humidification System (2004), 8 descendants of its own
- K013486: Vapotherm 2000H (2003), 7 descendants of its own
- K042245: Vapotherm Model#2000I, 200H (2004), 6 descendants of its own
- K072845: Precision Flow (2008), 2 descendants of its own
- K050314: Aquinox (2005), 1 descendant of its own

Source page: https://510kreport.com/device/K000401
Methodology: https://510kreport.com/methodology