Avea II
KIT, Heliox/AIR Connection, Avea II
8manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Vyaire Medical, Inc., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| 510(k) | K103211 |
| Record published | 2018-04-05 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32078-001 | In distribution | |
| 32194-001 | In distribution | |
| 32193-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201082 | 2021-11-10 |
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2016-05-17 | Class I | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Mod | 922 units total (501 units in US) | 2017-09-28 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2015-04-03 | Class I | Process control | A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe | 15,905 units total (5,670 units in US) | 2018-07-23 |
| Carefusion 211 Inc dba Carefusion | 510(k) number | 2013-09-05 | Class I | Component design/selection | CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a fiel | 19,546 units | 2015-06-04 |
| Carefusion 211 Inc | 510(k) number | 2011-09-08 | Not classified | Nonconforming Material/Component | The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating | 6797 total, 1891 in US, 4906 worldwide | 2013-10-29 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-05-05 | Class II | Nonconforming Material/Component | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang | 910 units | |
| 2023-05-05 | Class II | Nonconforming Material/Component | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang | 392 units | |
| 2021-12-20 | Class I | Software change control | Potential cessation in ventilation can occur under specific conditions. | 4189 units | 2024-08-28 |
| 2019-11-25 | Class II | Software design | The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a ‘no alarm’ condition, or presence of non-responsive touch screen. | 116 | 2023-08-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.