510(k) Report

FDA applicant

NeuroPace, Inc.

Mountain View, CA3 decisions2013–20140 recalls

FDA records 3 decisions for NeuroPace, Inc. (Mountain View, CA) from 2013 to 2014: 2 510(k) clearances and 1 original PMA approval. Most are in product codes GXR (Cover, Burr Hole) and PFN (Implanted Brain Stimulator For Epilepsy). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided NeuroPace, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 22014: 1
2013high 2 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — NeuroPace, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like NeuroPace, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GXRCover, Burr Hole2decisions
  • PFNImplanted Brain Stimulator For Epilepsy1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123163Neuropace Burr Hole Cover Model 8110NeuroPace, Inc. · 20133cite it
  • K141368Neuropace Burr Hole CoverNeuroPace, Inc. · 20141cites it

What has FDA decided for it lately?

  • K141368Neuropace Burr Hole CoverNeuroPace, Inc. · 2014
  • P100026Neuropace RNS SystemNeuroPace, Inc. · 2013
  • K123163Neuropace Burr Hole Cover Model 8110NeuroPace, Inc. · 2013

All 3 as NeuroPace, Inc. →