Palladium High Flow Therapy System— 510(k) K191010

Substantially Equivalent

Vapotherm, Inc.

FDA 510(k) clearance K191010 for Palladium High Flow Therapy System, Substantially Equivalent on 2019-10-10. Applicant: Vapotherm, Inc..

Clearance details

Applicant: Vapotherm, Inc.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2019-04-16
Decision date: 2019-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exeter, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.