Carescape
The listed R860 is the CARESCAPE R860 ventilator. Its FDA filing says it is designed to provide mechanical ventilation or support to neonatal, pediatric and adult patients weighing 0.25…
The listed R860 is the CARESCAPE R860 ventilator. Its FDA filing says it is designed to provide mechanical ventilation or support to neonatal, pediatric and adult patients weighing 0.25 kilograms and above.
The filing describes a microprocessor-based, electronically controlled, pneumatically driven ventilator with integrated monitoring of oxygen concentration, airway pressure, flow and volume.
Listed Item
Carescape R860
Facility Use
The system is designed for facility use, including transport within a facility, and should be used under a clinician’s orders. The filing notes that not all features are available for every patient type or configuration.
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 | Datex-Ohmeda, Inc., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K142679 |
| Record published | 2015-09-23 |
| Record revised | 2022-05-12 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -15 to 50 °C; Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 49.99 to 106.66 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R860 | 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 |
|---|---|
| K210384 | 2021-11-04 |
| K142679 | 2015-06-12 |
| K140575 | 2015-02-03 |
| K111116 | 2011-09-09 |
| K081842 | 2008-10-03 |
| K062710 | 2006-12-08 |
| K060862 | 2006-06-05 |
| K051895 | 2005-09-27 |
| K050860 | 2005-06-21 |
| K050597 | 2005-03-25 |
| K041775 | 2004-10-26 |
| K041524 | 2004-09-20 |
| K023366 | 2003-10-07 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2022-04-18 | Class I | Under Investigation by firm | Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. | 34,940 ventilators | |
| GE Medical Systems, LLC | 510(k) number | 2022-04-18 | Class I | Under Investigation by firm | Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply. | 88,379 batteries | |
| GE Medical Systems, LLC | 510(k) number | 2020-07-14 | Class II | Process control | The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered. | 2277 units | 2024-09-23 |
| GE Medical Systems, LLC | 510(k) number | 2018-10-05 | Class I | Process control | The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypox | 1140 units (307 units in US) | 2024-04-29 |
| GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | 510(k) number | 2018-06-28 | Class II | Under Investigation by firm | The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. | 417 units | 2019-02-22 |
| GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | 510(k) number | 2017-12-08 | Class II | Software change control | Potential for the display processor to experience an unexpected failure. | 349 (US) + 2,051 (OUS) | 2021-04-29 |
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.