TNI softFlow 50— 510(k) K180474

Name: FDA 510(k) clearance K180474
Creator: U.S. Food and Drug Administration
Published: 2018-10-18

Substantially Equivalent

Tni Medical AG

FDA 510(k) clearance K180474 for TNI softFlow 50, Substantially Equivalent on 2018-10-18. Applicant: Tni Medical AG. Device class: 2.

Clearance details

Applicant: Tni Medical AG
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 2018-02-22
Decision date: 2018-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuerzburg, DE

Download summary PDF View on FDA.gov ↗

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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.