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510(k) K221318

HVT 2.0 by Vapotherm, Inc. — Product Code QAV

K221318 is an FDA 510(k) premarket notification submitted by Vapotherm, Inc. for the device "HVT 2.0". The FDA issued a decision of Substantially Equivalent on December 13, 2022. The device falls under product code QAV (High Flow/High Velocity Humidified Oxygen Delivery Device), a Class II device regulated under 21 CFR 868.5454. Vapotherm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2022
Date Received
May 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Flow/High Velocity Humidified Oxygen Delivery Device
Device Class
Class II
Regulation Number
868.5454
Review Panel
AN
Submission Type

Intended to deliver high flow and/or high velocity oxygen with humidification.

Other clearances by Vapotherm, Inc.

  • K254078 — HVT 2.0 (April 13, 2026)
  • K220869 — Vapotherm Aerosol Adapter AAA-2 (October 28, 2022)
  • K203357 — HVT 2.0 (August 25, 2021)
  • K191010 — Palladium High Flow Therapy System (October 10, 2019)
  • DEN170001 — Precision Flow® HVNI (April 10, 2018)
  • K111640 — PRECISION FLOW(R) - HELIOX (October 7, 2011)
  • K103316 — FLOWREST (February 8, 2011)
  • K072845 — PRECISION FLOW (July 17, 2008)
  • K070056 — VAPOTHERM MODEL# 2000I AND 2000H (April 13, 2007)
  • K042245 — VAPOTHERM MODEL#2000I, 200H (August 30, 2004)

Other clearances for product code QAV

  • K221338 — F&P Airvo 3 (January 27, 2023)
  • DEN170001 — Precision Flow® HVNI (April 10, 2018)

FDA data resources