TRANSCEND HEATED HUMIDIFIER— 510(k) K131388

Substantially Equivalent

Somnetics International, Inc.

FDA 510(k) clearance K131388 for TRANSCEND HEATED HUMIDIFIER, Substantially Equivalent on 2013-09-26. Applicant: Somnetics International, Inc..

Clearance details

Applicant: Somnetics International, Inc.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2013-05-14
Decision date: 2013-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brighton, MN, US

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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.