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510(k) DEN170001

Precision Flow® HVNI by Vapotherm, Inc. — Product Code QAV

DEN170001 is an FDA 510(k) premarket notification submitted by Vapotherm, Inc. for the device "Precision Flow® HVNI". The FDA issued a decision of De Novo Granted on April 10, 2018. 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
DENG (De Novo Granted)
Decision Date
April 10, 2018
Date Received
January 3, 2017
Clearance Type
Direct
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)
  • K221318 — HVT 2.0 (December 13, 2022)
  • 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)
  • 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)
  • K221318 — HVT 2.0 (December 13, 2022)

FDA data resources