510(k) · Cleared
ClearediCE-SG Subcutaneous Electrode Arrays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ice Neurosystems, Inc. · GZL Electrode, Depth
Cleared on Mar 8, 2021 as substantially equivalent to K163355 (Ad-Tech Medical Instrument Corporation, 2017) and 1 other predicate after a 262-day review. Its family tree reaches back 7 generations to 1981. 1 later device descends from it.
- Decided
- Mar 8, 2021
- Review
- 262 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K811452 (1981). 19 ancestors in all, the oldest K802151 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 6 generations backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- 5 generations backK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- 4 generations backK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- 3 generations backK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- 2 generations backK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- 1 generation backK163355 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth…Ad-Tech Medical Instrument Corporation · 2017 · Recalled
- This deviceK201678 iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK222706 iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −6 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| −5 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| −4 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| −3 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| −2 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| −1 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | 5 |
| 0 (this device) | K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | 2021 | — |
| +1 | K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Summary page 4…Primary Predicate Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrode, Spencer Probe K163355 Depth Electrodes, Wyler… | 2017 |
| * | K961942 | Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth…Summary page 4…er Sphenoidal Depth Electrode) / Ad- tech Medical Instrument Corporation Epidural Peg Electrode (EP), Sphenoidal Electrode (EDS) K961942 and Foramen Ovale Depth Electrode (ED-FO) for Epilepsy Monitoring / Radionics Inc.… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222706 | iCE-SG2 Subcutaneous Electrode Kit | 2022 | 0 |
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 40 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K222706 (Ice Neurosystems, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K163355.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
iCE-SG Subcutaneous Electrode Arrays are intended for temporary (<14 days) use with recording and monitoring equipment for the recording and monitoring of electrical signals at the subsurface level of the brain.
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/K201678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201678: iCE-SG Subcutaneous Electrode Arrays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201678
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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