510(k) · Cleared
ClearediSyncBrain©-C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
iMediSync, Inc. · OLU Normalizing Quantitative Electroencephalograph Software
Cleared on Mar 16, 2023 as substantially equivalent to K171414 (Brainmaster Technologies, Inc., 2018) after a 177-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- Mar 16, 2023
- Review
- 177 days
- Class
- Class II
- Product code
- OLU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K801604 (1980). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK801604 Pathfinder Electrodiagnostic SystemNicolet Biomedical Instruments · 1980
- 3 generations backK974748 Neurometric Analysis SystemNxlink, Ltd. · 1998
- 2 generations backK041263 Neuroguide Analysis SystemApplied Neuroscience, Inc. · 2004
- 1 generation backK171414 qEEG-ProBrainmaster Technologies, Inc. · 2018
- This deviceK222838 iSyncBrain©-CiMediSync, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801604 | Pathfinder Electrodiagnostic System | Nicolet Biomedical Instruments | 1980 | — |
| −3 | K974748 | Neurometric Analysis System | Nxlink, Ltd. | 1998 | — |
| −2 | K041263 | Neuroguide Analysis System | Applied Neuroscience, Inc. | 2004 | — |
| −1 | K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | 2018 | — |
| 0 (this device) | K222838 | iSyncBrain©-C | iMediSync, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1995 | 2 | 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 OLU? 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 OLU device
- #1 K253015 Cognitive Function Neuroimaging (cfNI)…score 13.3 · 7 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 |
|---|---|---|---|
| * | K171414 | qEEG-ProSummary page 4…lograph • Classification Name: Electroencephalograph, Class II • Regulation: 21 CFR 882.1400 • Product Code: OLU IV. Predicate Device qEEG-Pro (K171414) V. Description iSyncBrain-C is a software program for the post-hoc statistical analysis of the human electroencephal… | 2018 |
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?
- The line of descent spans 43 years and passes through 5 companies; a new generation was cleared every 13.9 years on median.
- None of the 17 ancestors has a recall.
- 2 other devices also cite its predicate K171414.
How does its category compare?
All OLU devicesOLU Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OLU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OLU
Too few OLU 510(k)s in any year since 2007 to give a median.
Recalls per year · OLU
No recall names OLU since 2007.
Adverse event reports per year · OLU
1in 2025
MAUDE reports naming product code OLU, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The iSyncBrain-C is to be used by qualified medical or qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG) in patients aged 4.5 to 81 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222838 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222838: iSyncBrain©-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222838
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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