510(k) Report

FDA applicant

Ceribell, Inc.

Sunnyvale, CA16 decisions2017–20260 recalls

FDA records 16 decisions for Ceribell, Inc. (Sunnyvale, CA) from 2017 to 2026: 16 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and OMB (Automatic Event Detection Software For…). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 14 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 Ceribell, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2017: 22019: 12021: 12023: 32025: 42026 (partial year): 5
2017high 5 (2026) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ceribell, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • GXYElectrode, Cutaneous7decisions
  • OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph5decisions
  • OMCReduced- Montage Standard Electroencephalograph2decisions
  • NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid1decision
  • OLTNon-Normalizing Quantitative Electroencephalograph Software1decision

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 130 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 138 days; 6 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 14 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.

  • K170363Ceribell Pocket EEG DeviceCeribell, Inc. · 20177cite it
  • K171459Ceribell Instant EEG HeadbandCeribell, Inc. · 20175cite it
  • K191301Ceribell Pocket EEG DeviceCeribell, Inc. · 20195cite it
  • K232052Ceribell Instant EEG HeadbandCeribell, Inc. · 20233cite it
  • K223086Ceribell Instant EEG HeadcapCeribell, Inc. · 20232cite it
  • K210805Ceribell Instant EEG HeadbandCeribell, Inc. · 20212cite it

What has FDA decided for it lately?

  • K261712Ceribell EEG Analysis SoftwareCeribell, Inc. · 2026
  • K261101Ceribell MonitorCeribell, Inc. · 2026
  • K260998Ceribell Neurology Review SoftwareCeribell, Inc. · 2026
  • K260363Ceribell Brain Monitor HeadbandCeribell, Inc. · 2026
  • K254033Ceribell Instant EEG HeadsetCeribell, Inc. · 2026
  • K251936Ceribell Delirium Monitor SystemCeribell, Inc. · 2025
  • K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc. · 2025
  • K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)Ceribell, Inc. · 2025

All 16 as Ceribell, Inc. →