Data / Medical devices / United States / BRAINSPACE Inc
BRAINSPACE Inc: FDA-registered device maker in Bothell, WA, United States, 1 510(k) clearance
BRAINSPACE Inc is registered with the FDA (registration 3043513133) in Bothell, WA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043513133
- Address
- 22121 17th Ave Se Ste 112, Bothell, WA, United States, 98021
- Owner or operator
- BrainSpace (10095057)
- Roles
- Manufacturer
- First device listed
- January 19, 2026
- Registered through
- 2026
- Brand names listed
- Intellidrop
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Manufacturer | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | 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 |
|---|---|---|---|---|---|---|
| December 10, 2025 | K251598 | Intellidrop | JXG | Substantially Equivalent | Brainspace, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Shunt, Central Nervous System And Components
- All makers of Device, Monitoring, Intracranial Pressure
Updated December 10, 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.