Data / Medical devices / China / Apk Technology Co., Ltd
Apk Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 5 510(k) clearances
Apk Technology Co., Ltd is registered with the FDA (registration 3007699081) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 7, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007699081
- Address
- 6 Floor, B2 Building Industry of Hengfeng, No. 739, Zhoushi Road, Hezhou, Hangcheng Street, Baoan District, Shenzhen China, Shenzhen Guangdong, China, 518126
- Owner or operator
- APK Technology Co., Ltd (10029153)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- April 9, 2009
- Registered through
- 2027
- Brand names listed
- 10043, 10050, 10055, 10186, 10190 10453 S533-490 S543-490 S523-490 S403-490 S403S-490 S403-1250 S410-150, 10191 S803-080 10219 S803-060 10192 10724 S903-1250 S910-150 S543-050 10199 S110-090 S803-42D0, 10193, 10194 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Light, Ultraviolet, Dermatological | FTC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 7, 2025 | K250425 | Ultraviolet Phototherapy Device | FTC | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| June 8, 2018 | K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | DQA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| April 24, 2017 | K170536 | ECG Disposable Lead Wire | DSA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| March 2, 2011 | K102825 | BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| April 3, 2009 | K082846 | APK SPO2 PULSE OXIMETER SENSOR | DQA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Oximeter
- All makers of Cable, Electrode
- All makers of Blood Pressure Cuff
- All makers of Electrode, Electrocardiograph
- All makers of Light, Ultraviolet, Dermatological
Updated April 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.