NeuroPace, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “NeuroPace, Inc.” (first 2013, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 75 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 101 |
| 2014 | 1 | 49 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXR | Cover, Burr Hole | 2 | 2 |
| PFN | Implanted Brain Stimulator For Epilepsy | 1 | 0 |
Review panels
- Neurology (3)
Most recent NeuroPace, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141368 | NEUROPACE BURR HOLE COVER | GXR | 2014-07-11 | 49 |
| K123163 | NEUROPACE BURR HOLE COVER MODEL 8110 | GXR | 2013-01-18 | 101 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P100026 | PMA | NEUROPACE RNS SYSTEM | 2013-11-14 |
Recalls
openFDA lists no recalls under a recalling firm named NeuroPace, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named NeuroPace, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05339126: RNS System LGS Feasibility Study (Active not recruiting, started 2022-10-04)
- NCT05147571: RNS System NAUTILUS Study (Active not recruiting, started 2022-08-09)
- NCT02403843: RNS® System Epilepsy Post-Approval Study (Completed, started 2015-06)
- NCT00572195: RNS® System LTT Study (Completed, started 2006-04)
- NCT00264810: RNS® System Pivotal Study (Completed, started 2005-12)
SEC filings
NeuroPace Inc (NPCE): EDGAR filings, CIK 1528287. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under NeuroPace, Inc.?
FDA lists 2 510(k) clearances under the applicant name “NeuroPace, Inc.” (first 2013, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by NeuroPace, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name NeuroPace, Inc. is 75 days.
Which FDA product codes appear under NeuroPace, Inc.?
The most frequent FDA product codes under this applicant name are GXR (Cover, Burr Hole, 2); PFN (Implanted Brain Stimulator For Epilepsy, 1).
Next steps
- See all 2 NeuroPace, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXR, NeuroPace, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.