Data / Medical devices / United Kingdom / Prosum Medical Limited
Prosum Medical Limited: FDA-registered device maker in London London, City of, United Kingdom, 2 510(k) clearances
Prosum Medical Limited is registered with the FDA (registration 3029905131) in London London, City of, United Kingdom. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029905131
- Address
- Unit 14 Cowley Mill Road Uxbridge, London London, City of, United Kingdom, UB8 2DB
- Owner or operator
- Prosum Medical Limited (10088954)
- Roles
- Exporter to the US, Specification developer
- First device listed
- November 8, 2023
- Registered through
- 2026
- Brand names listed
- Blunt Fill Needle (without / with filter), Bubble Adaptor, Sterile, Single - use, Disposable Needle, Hypodermic Needle, Needle, Small Volume 0.2mL Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Specification developer | accessdata.fda.gov |
| Low Dead Space Piston Syringe | QNQ | 2 | Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US | 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 2, 2025 | K250138 | Small Volume 0.2mL Syringe | QNQ | Substantially Equivalent | Prosum Medical Limited | accessdata.fda.gov |
| December 12, 2023 | K233037 | Sterile Hypodermic Needles for Single Use | FMI | Substantially Equivalent | Zhejiang Kindly Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Low Dead Space Piston Syringe
- All makers of Dispenser, Liquid Medication
Updated April 2, 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.