510(k) Report

FDA applicant

Vapotherm, Inc.

Exeter, NH13 decisions2000–20269 recalls

FDA records 13 decisions for Vapotherm, Inc. (Exeter, NH) from 2000 to 2026: 12 510(k) clearances and 1 De Novo grant. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and QAV (High Flow/High Velocity Humidified Oxygen…). Its devices cite 19 predicates, 12 of them its own earlier devices. 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Vapotherm, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2007: 12008: 12011: 22018: 12019: 12021: 12022: 22026 (partial year): 1
2007high 2 (2011) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2022

2014: 82022: 1
2007high 8 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vapotherm, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vapotherm, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)10decisions
  • QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device2decisions
  • CAFNebulizer (Direct Patient Interface)1decision

Whose devices does it build on?

Its devices cite 19 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K000401Vapotherm, Model 2000IVapotherm, Inc. · 20005cite it
  • K042245Vapotherm Model#2000I, 200HVapotherm, Inc. · 20044cite it
  • K072845Precision FlowVapotherm, Inc. · 20082cite it
  • DEN170001Precision Flow® HVNIVapotherm, Inc. · 20182cite it
  • K191010Palladium High Flow Therapy SystemVapotherm, Inc. · 20191cites it
  • K103316FlowrestVapotherm, Inc. · 20111cites it

What has FDA decided for it lately?

  • K254078HVT 2.0Vapotherm, Inc. · 2026
  • K221318HVT 2.0Vapotherm, Inc. · 2022
  • K220869Vapotherm Aerosol Adapter AAA-2Vapotherm, Inc. · 2022
  • K203357HVT 2.0Vapotherm, Inc. · 2021
  • K191010Palladium High Flow Therapy SystemVapotherm, Inc. · 2019
  • DEN170001Precision Flow® HVNIVapotherm, Inc. · 2018
  • K111640Precision Flow (R) - HelioxVapotherm, Inc. · 20111 recall
  • K103316FlowrestVapotherm, Inc. · 2011

All 13 as Vapotherm, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K111640Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOWDec 16, 2022Class II
  • K072845Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the…Aug 13, 2014Class II
  • K072845Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox…Aug 13, 2014Class II
  • K072845Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged…Aug 13, 2014Class II
  • K072845Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the…Aug 13, 2014Class II
  • K072845Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the…Aug 13, 2014Class II