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Sign in to claim this brandVapotherm Inc.
United States·US-MF-000006231
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 100, Domain Drive, Exeter, United States
- Website
- www.Vapotherm.com
- —
- —
- [email protected]
- Phone
- 1-603-658-0011
- PRRC Contact
- Neeraj Pardhy
- EUDAMED SRN
- US-MF-000006231
- FDA FEI Number
- 3012971441
- DUNS Number
- —
Catalogue (408)
Page 9 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vapotherm Model#2000i, 200h | K042245 | FDA 510(k) | Class II | Active |
| Hvt 2.0 | K203357 | FDA 510(k) | Class II | Active |
| Flowrest | K103316 | FDA 510(k) | Class II | Active |
| Precision Flow® HVNI | DEN170001 | FDA 510(k) | Class II | Active |
| Precision Flow | K072845 | FDA 510(k) | Class II | Active |
| Hvt 2.0 | K254078 | FDA 510(k) | Class II | Active |
| Hvt 2.0 | K221318 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Vapotherm 2000h | K013486 | FDA 510(k) | Class II | Active |
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 16, 2022 | Z-1272-2023 | — | open, classified | There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout. |
| Aug 13, 2014 | Z-2701-2014 | — | terminated | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Z-2703-2014 | — | terminated | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Z-2699-2014 | — | terminated | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Z-2706-2014 | — | terminated | Water may leak into the center gas lumen of the Patient Circuit |
| Aug 13, 2014 | Z-2700-2014 | — | terminated | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Z-2702-2014 | — | terminated | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Z-2705-2014 | — | terminated | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Aug 13, 2014 | Z-2704-2014 | — | terminated | Disposable Patient Circuit that allows water to leak into the center gas lumen |
| Oct 13, 2005 | Z-0360-06 | — | terminated | A medical device firm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners. |