# Vapotherm, Inc.

- Location (FDA's records): Exeter, NH
- FDA decisions: 13 (2000–2026): 12 510(k) clearances and 1 De Novo grant
- Product codes: BTT (10), QAV (2), CAF (1)
- Predicates its devices cite: 19 (12 its own); citations of its devices by later devices: 17 (12 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Precision Medical, Inc.: 2 (https://510kreport.com/company/precision-medical)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)
- Aerogen, Ltd.: 1 (https://510kreport.com/company/aerogen)
- Maxtec, LLC: 1 (https://510kreport.com/company/maxtec)
- Bird Products Corp.: 1 (https://510kreport.com/company/bird-products)
- Caradyne, Ltd.: 1 (https://510kreport.com/company/caradyne)

## Firms that cite its devices most
- Pari Innovative Manufacturers, Inc.: 1 (https://510kreport.com/company/pari-innovative-manufacturers)
- Caradyne, Ltd.: 1 (https://510kreport.com/company/caradyne)
- Smiths Medical Asd, Inc.: 1 (https://510kreport.com/company/smiths-medical-asd)
- Perma Pure, LLC: 1 (https://510kreport.com/company/perma-pure)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)

## Its most-cited devices
- K000401: Vapotherm, Model 2000I (2000), cited by 5
- K042245: Vapotherm Model#2000I, 200H (2004), cited by 4
- K072845: Precision Flow (2008), cited by 2
- DEN170001: Precision Flow® HVNI (2018), cited by 2
- K191010: Palladium High Flow Therapy System (2019), cited by 1
- K103316: Flowrest (2011), cited by 1

## Recent decisions
- K254078: HVT 2.0 (Apr 13, 2026)
- K221318: HVT 2.0 (Dec 13, 2022)
- K220869: Vapotherm Aerosol Adapter AAA-2 (Oct 28, 2022)
- K203357: HVT 2.0 (Aug 25, 2021)
- K191010: Palladium High Flow Therapy System (Oct 10, 2019)
- DEN170001: Precision Flow® HVNI (Apr 10, 2018)
- K111640: Precision Flow (R) - Heliox (Oct 7, 2011)
- K103316: Flowrest (Feb 8, 2011)

Source page: https://510kreport.com/company/vapotherm