CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN— 510(k) K131912
Substantially EquivalentTeleflex, 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.. Device class: 2.
Clearance details
- Applicant
- Teleflex, Inc.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Recent devices under product code BTT
view allMore clearances from Teleflex, Inc.
view allAdverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131912
K-number listed on FDA's recall record- Z-1114-2020 — HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
- Z-1115-2020 — HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
- Z-1558-2015 — Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131912.
Data sourced from openFDA. This site is unofficial and independent of the FDA.