CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN— 510(k) K131912

Substantially Equivalent

Teleflex, Inc.

FDA 510(k) clearance K131912 for CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN, Substantially Equivalent on 2014-03-06. Applicant: Teleflex, Inc..

Clearance details

Applicant: Teleflex, Inc.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2013-06-26
Decision date: 2014-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.