AirLife Autofill Humidification Chamber— 510(k) K160764

Clearance details

Applicant

Carefusion 2200, Inc.

Product code

Code BTT

Device class

Class 2

Regulation

21 CFR 868.5450

Advisory panel

Anesthesiology

Date received

2016-03-21

Decision date

2016-08-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vernon Hills, IL, US

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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 →

• Z-0343-2018 — Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.Class I·Terminated·Vyaire Medical·20141129
• Z-0344-2018 — Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.Class I·Terminated·Vyaire Medical·20141129
• Z-0345-2018 — Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.Class I·Terminated·Vyaire Medical·20141129
• Z-0346-2018 — Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.Class I·Terminated·Vyaire Medical·20141129

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160764.