K-Systems
L126 MP, Standard Heat Right, AV5 Left, Monitor
3manufacturers in China registered for this device type
66catalogue numbers in this listing
1510(k) clearance
6recalls on this code
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1), Sichuan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd. | Pidu District Chengdu | Sichuan | Manufacturer | 3 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | PUB |
| Device type | Accessory, Assisted Reproduction, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-12 |
| Record revised | 2024-02-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6.112.511.121 | In distribution | |
| 6.133.811.121 | In distribution | |
| 6.131.811.121 | In distribution | |
| 6.121.312.121 | In distribution | |
| 6.133.911.121 | In distribution | |
| K23054 | In distribution | |
| K22076 | In distribution | |
| 6.111.511.121 | In distribution | |
| 6.132.911.121 | In distribution | |
| 4.212.421.232 | In distribution | |
| 4.212.422.232 | In distribution | |
| 6.111.311.121 | In distribution | |
| 6.121.212.121 | In distribution | |
| 6.112.312.121 | In distribution | |
| 6.132.811.121 | In distribution | |
| 6.111.212.121 | In distribution | |
| 4.211.321.232 | In distribution | |
| 6.122.311.121 | In distribution | |
| 6.111.211.121 | In distribution | |
| 6.131.812.121 | In distribution | |
| 4.112.212.121 | In distribution | |
| 4.141.142.314 | In distribution | |
| 6.134.911.121 | In distribution | |
| 6.121.211.121 | In distribution | |
| 6.112.311.121 | In distribution | |
| 4.111.211.121 | In distribution | |
| 4.111.311.121 | In distribution | |
| 4.212.321.232 | In distribution | |
| 4.112.312.121 | In distribution | |
| K23055 | In distribution | |
| 6.122.211.121 | In distribution | |
| 6.122.312.121 | In distribution | |
| 3.641.832.153 | In distribution | |
| 6.111.512.121 | In distribution | |
| 6.121.311.121 | In distribution | |
| 4.211.322.232 | In distribution | |
| 4.141.141.314 | In distribution | |
| 6.111.312.121 | In distribution | |
| 6.132.812.121 | In distribution | |
| 6.111.612.121 | In distribution | |
| 6.133.912.121 | In distribution | |
| 3.641.831.153 | In distribution | |
| 4.111.212.121 | In distribution | |
| K22074 | In distribution | |
| 6.112.612.121 | In distribution | |
| 6.112.212.121 | In distribution | |
| 6.131.911.121 | In distribution | |
| 4.212.322.232 | In distribution | |
| 6.134.811.121 | In distribution | |
| 6.112.611.121 | In distribution | |
| 6.131.912.121 | In distribution | |
| 4.111.312.121 | In distribution | |
| 6.132.912.121 | In distribution | |
| 6.134.912.121 | In distribution | |
| 6.112.211.121 | In distribution | |
| 4.211.422.232 | In distribution | |
| K22065 | In distribution | |
| 6.112.512.121 | In distribution | |
| 6.111.611.121 | In distribution | |
| K24012 | In distribution | |
| 4.112.311.121 | In distribution | |
| 6.122.212.121 | In distribution | |
| 4.112.211.121 | In distribution | |
| 6.133.812.121 | In distribution | |
| 6.134.812.121 | In distribution | |
| 4.211.421.232 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fortuna | Research Instruments Ltd | 28 |
| Mars | Research Instruments Ltd | 19 |
| Multi-zone ART Workstation | Esco Medical Technologies, UAB | 13 |
| CT37 Incubator | Planer Limited | 9 |
| Titan | Research Instruments Ltd | 7 |
| Multiroom IVF incubator | Esco Medical Technologies, UAB | 6 |
| K-Systems | Research Instruments Ltd | 6 |
| Hariomed | HUA YUE Medical Technology Co., Ltd. | 4 |
| G185 | Research Instruments Ltd | 4 |
| PHCbi | PHC Corporation | 3 |
| BT37 | Planer Limited | 2 |
| Aire~Lifeline | Lifeaire Systems | 2 |
Showing 12 of 27. All products under Accessory, Assisted Reproduction, Exempt
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191020 | 2020-01-14 |
Recalls
6 of these are Class II. 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 |
|---|---|---|---|---|
| 2024-11-15 | Class II | Process change control | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | 43 units |
| 2024-11-15 | Class II | Process change control | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | 106 units |
| 2024-11-15 | Class II | Process change control | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | 22 units |
| 2024-11-15 | Class II | Process change control | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | 35 units |
| 2024-11-15 | Class II | Process change control | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | 37 units |
| 2024-11-15 | Class II | Process change control | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | 34 units |
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.