510(k) · Cleared
ClearedcortiQ PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G.Tec Medical Engineering GmbH · OLU Normalizing Quantitative Electroencephalograph Software
Cleared on Jan 24, 2020 as substantially equivalent to K041263 (Applied Neuroscience, Inc., 2004) and 1 other predicate after a 240-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jan 24, 2020
- Review
- 240 days
- Class
- Class II
- Product code
- OLU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001564 (2000). 20 ancestors in all, the oldest K801604 (1980). No later device cites it as a predicate yet.
- Root · 4 generations backK001564 Scan LT40 (40 Channels)Neuro Scan Labs · 2000
- 3 generations backK023536 NuampsNeuroscan · 2003
- 2 generations backK060803 G.UsbampG.Tec Medical Engineering GmbH · 2006
- 1 generation backK123255 g.HIampG.Tec Medical Engineering GmbH · 2012
- This deviceK191432 cortiQ PROG.Tec Medical Engineering GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001564 | Scan LT40 (40 Channels) | Neuro Scan Labs | 2000 | — |
| −3 | K023536 | Nuamps | Neuroscan | 2003 | — |
| −2 | K060803 | G.Usbamp | G.Tec Medical Engineering GmbH | 2006 | — |
| −1 | K123255 | g.HIamp | G.Tec Medical Engineering GmbH | 2012 | — |
| 0 (this device) | K191432 | cortiQ PRO | G.Tec Medical Engineering GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 3 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2004 | 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 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? (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 |
|---|---|---|---|
| * | K041263 | Neuroguide Analysis SystemSummary page 4…Product Code: OLU, OLT, GWL 807.92(a)(3) Predicate Device(s) K# K041263 (primary predicate) K123255 (secondary predicate) Trade/Device Name NeuroGuide Analys… | 2004 |
| * | K123255 | g.HIampSummary page 4…(a)(3) Predicate Device(s) K# K041263 (primary predicate) K123255 (secondary predicate) Trade/Device Name NeuroGuide Analysis System g.HIamp Regulatio… | 2012 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 20 ancestors has a recall.
- 8 other devices also cite its predicate K041263.
How does its category compare?
All OLU devicesOLU Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform.
cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.HIamp.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191432: cortiQ PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191432
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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