510(k) · Cleared
Recalled · Class II · 2014Cueva Cranial Nerve Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad-Tech Medical Instrument Corp · GZL Electrode, Depth
Cleared on Jan 20, 1995 after a 154-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 20, 1995
- Review
- 154 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK944061 Cueva Cranial Nerve ElectrodeAd-Tech Medical Instrument Corp · 1995
- Descendant · cites it directly · 1 of its ownK230853 EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK241917 EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC · 2024
- Descendant · cites it directly · 0 of its ownK152769 Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016
- Descendant · cites it directly · 0 of its ownK152547 DNAP ElectrodeAd-Tech Medical Instrument Corporation · 2016
Most influential descendants
Showing 4 of 4 · See all- K230853EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc. · 2023 · cites it directly1descendant
- K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLC · 2024 · 2 generations on0descendants
- K152769Fremap ElectrodeAd-Tech Medical Instrument Corporation · 2016 · cites it directly0descendants
- K152547DNAP ElectrodeAd-Tech Medical Instrument Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944061 | Cueva Cranial Nerve Electrode | Ad-Tech Medical Instrument Corp | 1995 | — |
| +1 | K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | 2023 | — |
| +2 | K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | 2024 | — |
| +1 | K152769 | Fremap Electrode | Ad-Tech Medical Instrument Corporation | 2016 | — |
| +1 | K152547 | DNAP Electrode | Ad-Tech Medical Instrument Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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 |
|---|---|---|---|---|
| Oct 8, 2014 | Class II | Z-0106-2015 | Process control | The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. . |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K230853 (Nvision Biomedical Technologies, Inc., 2023) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K944061 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944061: Cueva Cranial Nerve Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944061
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026