510(k) · Cleared
ClearedDepth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Sinovation Medical Technology Co., Ltd. · GZL Electrode, Depth
Cleared on Nov 5, 2025 as substantially equivalent to K222404 (Neuroone Medical Technologies Corp., 2022) and 2 other predicates after a 268-day review. Its family tree reaches back 9 generations to 1981.
- Decided
- Nov 5, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K811452 (1981). 22 ancestors in all, the oldest K802151 (1980). No later device cites it as a predicate yet.
- Root · 9 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 5 generations between
- 3 generations backK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- 2 generations backK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
- 1 generation backK222404 Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022
- This deviceK250363 Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 8 generations backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- 7 generations backK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- 6 generations backK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- 5 generations backK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- 4 generations backK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- 3 generations backK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- 2 generations backK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
- 1 generation backK222404 Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022
- This deviceK250363 Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −8 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| −7 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| −6 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| −5 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| −4 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| −3 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
| −2 | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
| −1 | K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1980 | 1 | 0 |
| 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 |
| 2017 | 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 |
|---|---|---|---|
| * | K222404 | Evo® sEEG SystemSummary page 5…ification Name: Depth Electrode(21 CFR 882.1330) Regulatory Class: II Product Code: GZL III. Predicate device Predicate Device: Evo@sEEG System Predicate 510(K) number: K222404 Manufacture:NeuroOne Medical Technolohies Corp. The 510(k) summary of the predicate device is provided as K222404.pdf This predic… | 2022 |
| * | K170959 | DIXI Medical Microdeep Depth ElectrodeSummary page 5…rovided as K222404.pdf This predicate has not been subject to a design-related recall. Predicate Device: DIXI Medical Microdeep Depth Electrode Predicate 510(K) number: K170959 Manufacture: DIXI Medical. The 510(k) summary of the predicate device is provided as K170959.pdf Predicate Device: Depth Electro… | 2017 |
| * | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Summary page 5…er: K170959 Manufacture: DIXI Medical. The 510(k) summary of the predicate device is provided as K170959.pdf Predicate Device: Depth Electrodes Predicate 510(K) number: K163355 Manufacture: Ad-tech Medical Instrument Corporation The 510(k) summary of the predicate device is provided as K163355.pdf No ref… | 2017 |
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 44 years and passes through 7 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 22 ancestors have a recall of any class.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Depth Electrode is intended for temporary (less than 30 days) 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/K250363 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250363: Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250363
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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