510(k) · Cleared
ClearedCadwell Spike and Seizure Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Jul 23, 2014 as substantially equivalent to K011397 (Persyst Development Corp., 2001) after a 141-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 23, 2014
- Review
- 141 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011397 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011397 Persyst RevealPersyst Development Corp. · 2001
- This deviceK140552 Cadwell Spike and Seizure DetectorCadwell · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011397 | Persyst Reveal | Persyst Development Corp. | 2001 | — |
| 0 (this device) | K140552 | Cadwell Spike and Seizure Detector | Cadwell | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMB device
- #1 K240993 encevis (2.1)score 15.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011397 | Persyst RevealSummary page 1…Class 11,21 CFR 882.1400 Product Code: 0MB Classification Panel: Neurology Predicate Device: Persyst Reveal (K011397) Device Description: Cadwell Spike and Seizure Detector is a software-only… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K011397.
How does its category compare?
All OMB devicesOMB Automatic Event Detection Software For Full-Montage Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OMB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMB
143in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMB
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMB
6in 2025
MAUDE reports naming product code OMB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 3 | 233 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 108 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 5 | 201 | 0 | 21 |
| 2025 | 5 | 143 | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Cadwell Spike and Seizure Detector is a software-only product with an algorithm intended to analyze and mark events that may correspond to epileptiform discharge (spike) and electrographic seizure for the purpose of reviewing scalp EEG recordings. The marked events are reviewed, deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.
This device does not control the delivery of energy, administration of drugs, or another form of life sustaining function to the patient. It is intended for use in patients who are 18 years or over.
This device does not provide any diagnostic conclusion about the patient to the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140552 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140552: Cadwell Spike and Seizure Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140552
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026