Data / Medical devices / United States / Neuropace
Neuropace: FDA-registered device maker in Mountain View, CA, United States, 1 510(k) clearance and 1 PMA approval
Neuropace is registered with the FDA (registration 3004426659) in Mountain View, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated July 11, 2014. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004426659
- Address
- 455 N. Bernardo Avenue, Mountain View, CA, United States, 94043
- Owner or operator
- NeuroPace (10044401)
- Roles
- Manufacturer
- First device listed
- December 2, 2013
- Registered through
- 2026
- Brand names listed
- NeuroPace Burr Hole Cover, NeuroPace RNS System, RNS System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Burr Hole | GXR | 2 | Manufacturer | accessdata.fda.gov |
| Implanted Brain Stimulator For Epilepsy | PFN | 3 | 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 |
|---|---|---|---|---|---|---|
| July 11, 2014 | K141368 | NEUROPACE BURR HOLE COVER | GXR | Substantially Equivalent | NeuroPace, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 14, 2013 | P100026 | NEUROPACE RNS SYSTEM | PFN | 98 | August 19, 2026 | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2026. 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.