Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc.
Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc. (California): 510(k) cleared for Ceribell, Inc. Its amount of 117 is below the median of 138 (43rd percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 117 · 43th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261712 |
| Device | Ceribell EEG Analysis Software |
| Applicant | Ceribell, Inc. |
| Specialty / panel | Neurology |
| Product code | OLT |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-22 |
| Decision date | 2026-09-16 |
| Review time (days) | 117 |
| Third-party review | No |
| Applicant location | Sunnyvale, CA, US |
| amount percentile | 43th of 414 (median 138, 0.8x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CA first): Triever Duo Catheter (K253419) · Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc.'s amount: 43rd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 117-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc. in California?
Ceribell EEG Analysis Software (K261712) by Ceribell, Inc. was cleared on 2026-09-16 after 117 days of review.
How does Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc. compare to other California FDAPulse records?
Its amount of 117 is below the median (43th percentile); smaller records often move faster and face less competition. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
Ceribell EEG Analysis Software (K261712) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ceribell EEG Analysis Software (K261712) | CA | 2026-09-16 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
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