Ceribell Status Epilepticus Monitor

K223504

Ceribell, Inc. · cleared 2023-05-23 · product code OMB · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The Ceribell Status Epilepticus Monitor is a software as medical device that analyzes EEG waveforms for the intended use of recognizing electrographic status epilepticus (ESE).”
AlgorithmESE detection algorithm; processes electrographic seizure detections to make a determination regarding ESE
source quote (p.5)
“The 10 electrodes form 8 channels (4 on the left hemisphere, 4 on the right hemisphere) that are analyzed by the subject device's ESE detection algorithm. The subject device and predicate devices both contain algorithms to detect electrographic seizures, and in both the subject device and predicate device the design of the electrographic seizure detection is the same. Then the subject device additionally processes the electrographic seizure detections to make a determination regarding ESE.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=350 patients · 6 site(s)

endpoints: diagnosis of Electrographic Status Epilepticus (ESE)

Bench

sample size not stated

endpoints: processing of ESE data and the display of ESE output (ESE detected/ESE not detected); absence of unexpected effect or unintended regressions with underlying Pocket EEG Device software

Reported performance (2 observations)

sensitivity100CI [100%, 100%]
source quote (p.9)
“Sensitivity 100% [100%, 100%]”
specificity94CI [91%, 96%]
source quote (p.9)
“Specificity 94% [91%, 96%]”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
-100%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

ntap2023-10-01

NTAP max add-on $913.9 (active) ·

CMS granted NTAP beginning FY2024 (max add-on $913.90/case) for the ClarityPro AI software that analyzes EEG to detect electrographic status epilepticus; billed under ICD-10-PCS XX20X89. Listed as continuing in the FY2025 and FY2026 IPPS final rules (FY2026 is its final NTAP year). Facility inpatient add-on only. Dollar figure read from CMS MAC Implementation File 8.

CMS FY2024 IPPS Final Rule MAC Implementation File 8CMS FY2026 IPPS Final Rule MAC Implementation File 8 (continued NTAP)Ceribell FDA 510(k) + CMS NTAP press release

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K223504