510(k) · Cleared
ClearedDixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dixi Medical · GYC Electrode, Cortical
Cleared on Oct 2, 2021 as substantially equivalent to K191186 (Ad-Tech Medical Instrument Corporation, 2020) after a 446-day review. Its family tree reaches back 4 generations to 1985. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 2, 2021
- Review
- 446 days
- Class
- Class II
- Product code
- GYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K850342 (1985). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK850342 Wyler Subdural Strip ElectrodeAd-Tech Medical Instrument Corp · 1985
- 3 generations backK021144 Subdural Strip ElectrodeNicolet Biomedical, Inc. · 2002
- 2 generations backK053363 Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural…Ad-Tech Medical Instrument Corp · 2006 · Recalled (Class I)
- 1 generation backK191186 Subdural Strip/Intraoperative Split Electrode, Subdural…Ad-Tech Medical Instrument Corporation · 2020
- This deviceK201931 Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical · 2021
Class I recalls in this family
- K053363 Dual-Sided Interhemispheric Subdural Electrodes…2 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850342 | Wyler Subdural Strip Electrode | Ad-Tech Medical Instrument Corp | 1985 | — |
| −3 | K021144 | Subdural Strip Electrode | Nicolet Biomedical, Inc. | 2002 | — |
| −2 | K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes… | Ad-Tech Medical Instrument Corp | 2006 | Class I |
| −1 | K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative… | Ad-Tech Medical Instrument Corporation | 2020 | — |
| 0 (this device) | K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | Dixi Medical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 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.
1 device in this family has a Class I recall. 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 GYC device
- #1 K191186 Subdural Strip/Intraoperative Split Electrode…score 11.3 · 3 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 |
|---|---|---|---|
| * | K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…Summary page 4…II Product Code: GYC III. PREDICATE DEVICE The predicate device is the Ad-Tech Medical Instrument Corporation’s Subdural Cortical Electrodes (K191186). There have been no recalls for the predicate device. IV. DEVICE DESCRIPTION The DIXI Medical Intraoperative Subdural Elect… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K053363Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural ElectrodesAd-Tech Medical Instrument Corp · 2006 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 4 companies; a new generation was cleared every 13.7 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K191186.
How does its category compare?
All GYC devicesGYC Electrode, Cortical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GYC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GYC
Too few GYC 510(k)s in any year since 2007 to give a median.
Recalls per year · GYC
1in 2013
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GYC
2in 2025
MAUDE reports naming product code GYC, 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 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 3 | 6 |
| 2012 | 0 | — | 1 (1) | 17 |
| 2013 | 0 | — | 1 | 5 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) are intended for intraoperative use for less than or equal to 24 hours with recording and stimulation equipment for the recording and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports brain mapping.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201931: Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201931
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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