Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Palladium High Flow Therapy System

K-Number: K191010 · 2019-10-10

ApplicantVapotherm, Inc.
Decision Date2019-10-10
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Palladium High Flow Therapy System is a medical device manufactured by Vapotherm, Inc.. It received FDA 510(k) clearance on 2019-10-10 under approval number K191010. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Palladium High Flow Therapy System?

Palladium High Flow Therapy System is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Vapotherm, Inc.. The 510(k) number is K191010.

When was Palladium High Flow Therapy System approved by the FDA?

Palladium High Flow Therapy System received FDA 510(k) clearance on 2019-10-10, under approval number K191010.

What company makes Palladium High Flow Therapy System?

Palladium High Flow Therapy System is manufactured by Vapotherm, Inc..

What is the FDA product code for Palladium High Flow Therapy System?

The FDA product code for Palladium High Flow Therapy System is BTT.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Vapotherm, Inc.

DEN170001Precision Flow® HVNI K203357HVT 2.0 K221318HVT 2.0 K220869Vapotherm Aerosol Adapter AAA-2 K254078HVT 2.0

Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEFlexicare Medical Limited. K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K161719Salter Labs Bubble HumidifierSalter Labs K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑