HVT 2.0— 510(k) K221318

Name: FDA 510(k) clearance K221318
Creator: U.S. Food and Drug Administration
Published: 2022-12-13

Substantially Equivalent

Vapotherm, Inc.

FDA 510(k) clearance K221318 for HVT 2.0, Substantially Equivalent on 2022-12-13. Applicant: Vapotherm, Inc.. Device class: 2.

Clearance details

Applicant: Vapotherm, Inc.
Product code: Code QAV
Device class: Class 2
Regulation: 21 CFR 868.5454
Advisory panel: Anesthesiology
Date received: 2022-05-06
Decision date: 2022-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exeter, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAV

view all

K221338 — F&P Airvo 32023-01-27
DEN170001 — Precision Flow® HVNI2018-04-10

More clearances from Vapotherm, Inc.

view all

K254078 — HVT 2.02026-04-13
K220869 — Vapotherm Aerosol Adapter AAA-22022-10-28
K203357 — HVT 2.02021-08-25
K191010 — Palladium High Flow Therapy System2019-10-10
K111640 — PRECISION FLOW(R) - HELIOX2011-10-07

Adverse events under product code QAV

product code QAV

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.