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510(k) K191010

Palladium High Flow Therapy System by Vapotherm, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2019
Date Received
April 16, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Vapotherm, Inc.

  • K221318 — HVT 2.0 (December 13, 2022)
  • K220869 — Vapotherm Aerosol Adapter AAA-2 (October 28, 2022)
  • K203357 — HVT 2.0 (August 25, 2021)
  • 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)
  • K013486 — VAPOTHERM 2000H (May 30, 2003)

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  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)