510(k) · Cleared
Recalled · Class II · 2021DIXI Medical Microdeep Depth Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dixi Medical · GZL Electrode, Depth
Cleared on Nov 24, 2017 as substantially equivalent to K151790 (Pmt Corporation, 2016) and 2 other predicates after a 238-day review. Its family tree reaches back 6 generations to 1981. 5 later devices descend from it. It has been recalled 9 times.
- Decided
- Nov 24, 2017
- Review
- 238 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 9
- Predicates
- 3
Its longest line of descent runs back 6 generations to K811452 (1981). 17 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 5 generations backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- 4 generations backK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- 3 generations backK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- 2 generations backK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- 1 generation backK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- This deviceK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017
- Descendant · cites it directly · 2 of its ownK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
- Descendant · cites it directly · 1 of its ownK213170 SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK222404 Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK253970 Wovyn Depth ElectrodeSensomedical Labs, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250363 Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K211367Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021 · cites it directly2descendants
- K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023 · cites it directly1descendant
- K222404Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022 · 2 generations on1descendant
- K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd. · 2026 · 2 generations on0descendants
- K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −5 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| −4 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| −3 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| −2 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| −1 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| 0 (this device) | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | — |
| +1 | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
| +1 | K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023 | — |
| +2 | K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022 | — |
| +2 | K253970 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | 2026 | — |
| +1 | K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode… | Beijing Sinovation Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GZL? 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 GZL device
- #1 K253970 Wovyn Depth Electrodescore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K151790 | PMT Platinum Depthalon Depth ElectrodeSummary page 5…K170959 - Page 2 of 4 510(k) SUMMARY (CONT.) III. PREDICATE DEVICES [807.92(a)(3)] PMT® Platinum Depthalon® Depth Electrodes (K151790) AD-TECH Medical Instrumentation Corporation Depth Electrodes (K053358) Radionics Recording and Stimulating… | 2016 |
| * | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesSummary page 5…PREDICATE DEVICES [807.92(a)(3)] PMT® Platinum Depthalon® Depth Electrodes (K151790) AD-TECH Medical Instrumentation Corporation Depth Electrodes (K053358) Radionics Recording and Stimulating Electrode (K012850) IV. DEVICE DESCRIPTION [807.92(a)(4)] The DIXI Medi… | 2006 |
| * | K012850 | Recording and Stimulating ElectrodeSummary page 5…n® Depth Electrodes (K151790) AD-TECH Medical Instrumentation Corporation Depth Electrodes (K053358) Radionics Recording and Stimulating Electrode (K012850) IV. DEVICE DESCRIPTION [807.92(a)(4)] The DIXI Medical Microdeep Depth Electrode (“Microdeep Depth Electrode” or… | 2001 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2021 | Class II | Z-0535-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Dec 9, 2021 | Class II | Z-0536-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Dec 9, 2021 | Class II | Z-0538-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Dec 9, 2021 | Class II | Z-0539-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Dec 9, 2021 | Class II | Z-0537-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Dec 9, 2021 | Class II | Z-0541-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Dec 9, 2021 | Class II | Z-0542-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Dec 9, 2021 | Class II | Z-0540-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| Dec 9, 2021 | Class II | Z-0534-2022 | Under Investigation by firm | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K211367 (Neuroone Medical Technologies Corp., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K151790.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZL
206in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZL
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZL
12in 2025
MAUDE reports naming product code GZL, 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 | 3 | 166 | 0 | 0 |
| 2008 | 0 | — | 3 | 8 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 25 |
| 2014 | 1 | — | 1 | 7 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 222 | 0 | 3 |
| 2018 | 3 | 58 | 0 | 2 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 24 |
| 2021 | 3 | 262 | 9 | 13 |
| 2022 | 3 | 90 | 0 | 10 |
| 2023 | 3 | 206 | 0 | 30 |
| 2024 | 0 | — | 3 | 16 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DIXI Medical Microdeep Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170959: DIXI Medical Microdeep Depth Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170959
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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