510(k) · Cleared
ClearedICTA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Excel-Tech Ltd. (Xltek) · OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Cleared on Jun 29, 2012 as substantially equivalent to K090019 (Natus Medical, Inc., 2010) after a 154-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Jun 29, 2012
- Review
- 154 days
- Class
- Class II
- Product code
- OMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090019 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK090019 Natus Neuroworks, Model 104196Natus Medical, Inc. · 2010 · Recalled
- This deviceK120260 ICTAExcel-Tech Ltd. (Xltek) · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090019 | Natus Neuroworks, Model 104196 | Natus Medical, Inc. | 2010 | 1 |
| 0 (this device) | K120260 | ICTA | Excel-Tech Ltd. (Xltek) | 2012 | — |
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 |
|---|---|---|---|
| * | K090019 | Natus Neuroworks, Model 104196Summary page 1…ion Name: Automatic event detection software for full-montage electroencephalograph. Product code: 0MB Device Class: 11 Predicate Devices: NeuroWorks Seizure Detector (K090019) Description IOTA is a software only product. It runs on a personal computer and requires no specialized hardware. It identifie… | 2010 |
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 a recall.
- 2 other devices also cite its predicate K090019.
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. 2012, 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?
The ICTA software is intended as a review tool to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings (surface or intracranial) that may correspond to electrographic seizures, in order to assist qualified clinical practitioners, who will exercise professional judgment in using the information, in the assessment of EEG traces.
Surface recordings must be obtained with full montage according to the standard 10/20 system.
Intracranial recordings must be obtained with depth electrodes (strips and/or grids).
This device does not provide any diagnostic conclusion about the patient's condition to the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120260: ICTA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120260
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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