Data / Medical devices / United States / Branchpoint
Branchpoint: FDA-registered device maker in Placentia, CA, United States, 1 510(k) clearance
Branchpoint is registered with the FDA (registration 3023540124) in Placentia, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 18, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023540124
- Address
- 570 S Melrose St, Placentia, CA, United States, 92870
- Owner or operator
- Branchpoint & Aura Development LLC (10089340)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 29, 2023
- Registered through
- 2026
- Brand names listed
- AURA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 18, 2018 | K172209 | AURA ICP MONITORING SYSTEM | GWM | Substantially Equivalent | Branchpoint Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 18, 2018. 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.