Data / Medical devices / United Kingdom / Acurable Limited
Acurable Limited: FDA-registered device maker in London, United Kingdom, 2 510(k) clearances
Acurable Limited is registered with the FDA (registration 3024891505) in London, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024891505
- Address
- 83 Victoria Street, London, United Kingdom, SW1H 0HW
- Owner or operator
- Acurable Limited (10086249)
- Roles
- Exporter to the US, Specification developer
- First device listed
- October 26, 2022
- Registered through
- 2026
- Brand names listed
- AcuPebble Ox100, AcuPebble SA100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilatory Effort Recorder | MNR | 2 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 3, 2023 | K222950 | AcuPebble OX100 | MNR | Substantially Equivalent | Acurable Limited | accessdata.fda.gov |
| July 6, 2021 | K210480 | AcuPebble SA | MNR | Substantially Equivalent | Acurable Limited | accessdata.fda.gov |
Compare with other makers
Updated February 3, 2023. 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.