510(k) · Cleared
ClearedCliniscansm Eeg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Picofemto, LLC · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on May 15, 2015 as substantially equivalent to K011397 (Persyst Development Corp., 2001) and 1 other predicate after a 308-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 15, 2015
- Review
- 308 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001781 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK001781 Curry Multimodal Neuroimaging SoftwareNeurosoft, Inc. · 2001
- This deviceK141883 Cliniscansm EegPicofemto, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001781 | Curry Multimodal Neuroimaging Software | Neurosoft, Inc. | 2001 | — |
| 0 (this device) | K141883 | Cliniscansm Eeg | Picofemto, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
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? (2)
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 4…n 21 CFR 882.1400 Number: Predicate The CliniscanSM EEG is substantially equivalent to the Persyst ® Reveal [FDA 510(k) Devices: number K011397] and Neurosoft Curry 7 [FDA 510(k) number K001781]. Device CliniscanSM EEG, a Picofemto product, is a clin… | 2001 |
| * | K001781 | Curry Multimodal Neuroimaging SoftwareSummary page 4…The CliniscanSM EEG is substantially equivalent to the Persyst ® Reveal [FDA 510(k) Devices: number K011397] and Neurosoft Curry 7 [FDA 510(k) number K001781]. Device CliniscanSM EEG, a Picofemto product, is a clinical decision support system for medical Descripti… | 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?
- None of the 2 ancestors has a 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. 2015, 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?
1. CliniscanSM EEG is a clinical decision support system for medical data, to assist healthcare professionals in the visualization and analysis of EEG data. 2. The Seizure Detection component of CliniscanSM EEG is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. 3.…
Read the full statement (186 words)
1. CliniscanSM EEG is a clinical decision support system for medical data, to assist healthcare professionals in the visualization and analysis of EEG data.
2. The Seizure Detection component of CliniscanSM EEG is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces.
3. CliniscanSM EEG is intended for use on EEG recordings acquired using full scalp montage according to the standard 10/20 system.
4. The user may annotate the data, and the annotations are stored with the EEG recording in the cloud.
5. CliniscanSM EEG displays standard qEEG features to the user including FFT Power Spectrum, Coherence Mapping (EEG Activity Mapping), Density Spectral Array, EEG Localization Maps, and Wavelet Subband Decomposition (Delta, Theta, Alpha, Beta, and Gamma).
6. CliniscanSM EEG detects seizure events for review by qualified medical professionals.
7. CliniscanSM EEG is designed to provide analytics data derived from a patient’s input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141883: Cliniscansm Eeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141883
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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