Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Vapotherm with 12 510(k) clearances and 9 device recalls. The most recent is a 510(k) clearance dated Apr 13, 2026: HVT 2.0.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 13, 2026 | HVT 2.0K254078 · BTT | 510(k) clearances |
| Dec 16, 2022 | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOWClass II · There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circui | Device recalls |
| Dec 13, 2022 | HVT 2.0K221318 · QAV | 510(k) clearances |
| Oct 28, 2022 | Vapotherm Aerosol Adapter AAA-2K220869 · CAF | 510(k) clearances |
| Aug 25, 2021 | HVT 2.0K203357 · BTT | 510(k) clearances |
| Oct 10, 2019 | Palladium High Flow Therapy SystemK191010 · BTT | 510(k) clearances |
| Apr 10, 2018 | Precision Flow® HVNIDEN170001 · QAV | 510(k) clearances |
| Oct 7, 2011 | PRECISION FLOW(R) - HELIOXK111640 · BTT | 510(k) clearances |
| Feb 8, 2011 | FLOWRESTK103316 · BTT | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
