510(k) · Cleared
ClearedRecording and Stimulating Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, A Division of Tyco Healthcare Group LP · GZL Electrode, Depth
Cleared on Nov 19, 2001 as substantially equivalent to K991399 (Radionics, Inc., 1999) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1999. 6 later devices descend from it.
- Decided
- Nov 19, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991077 (1999). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK991077 Microelectroencephalography Professional System 5000 (Eeg Pro System…Microrecording Systems Consultants, LLC · 1999
- This deviceK012850 Recording and Stimulating ElectrodeRadionics, A Division of Tyco Healthcare Group LP · 2001
- Descendant · cites it directly · 5 of its ownK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
- Descendant · 2 generations on · 1 of its ownK213170 SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK222404 Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022
- Descendant · 3 generations on · 0 of its ownK253970 Wovyn Depth ElectrodeSensomedical Labs, Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · cites it directly5descendants
- K211367Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021 · 2 generations on2descendants
- K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023 · 2 generations on1descendant
- K222404Evo® sEEG SystemNeuroone Medical Technologies Corp. · 2022 · 3 generations on1descendant
- K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991077 | Microelectroencephalography Professional System 5000 (Eeg Pro System 5000) | Microrecording Systems Consultants, LLC | 1999 | — |
| 0 (this device) | K012850 | Recording and Stimulating Electrode | Radionics, A Division of Tyco Healthcare Group LP | 2001 | — |
| +1 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
| +2 | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
| +2 | K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023 | — |
| +3 | K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | 2022 | — |
| +3 | K253970 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K991399 | Radionics Microelectrode KitSummary page 1…rhnon/Usual Name: Recording Electrode and/ot Stimulating Electrode Classification Name: Depth Eleetrode Predicate Deviee(s): Radiontes Microelectrode Kit, 510(k) number K991399, dated Scpiember 21, 1999. Microvecording Systems Consullants, LI.C, Microelecirocncephalography Professional System 5000 for Su… | 1999 |
| * | K991077 | Microelectroencephalography Professional System 5000 (Eeg Pro System 5000)Summary page 1…ember 21, 1999. Microvecording Systems Consullants, LI.C, Microelecirocncephalography Professional System 5000 for Surgical Neurophysiological Recording, $10(k) numbcer K991077, dated June 9, 1999. Nttended Use: To record electrical activity or cvoke a responsc through stimulation for the purpose of bra… | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170959 | DIXI Medical Microdeep Depth Electrode | 2017 | 5 |
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?
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
T'o record cleetrical activity or evoke a responsc through stimulation for the purposc of brain wmapping during (unctional neurosurgical procedures.
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/K012850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012850: Recording and Stimulating Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012850
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026