510(k) · Cleared
ClearedDisposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · GXZ Electrode, Needle
Cleared on May 5, 2005 as substantially equivalent to K991583 (The Magstim Company, Ltd., 1999) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1992. 38 later devices descend from it.
- Decided
- May 5, 2005
- Review
- 85 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K923056 (1992). 4 ancestors in all. 38 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 1 generation backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- This deviceK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- Descendant · cites it directly · 32 of its ownK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- Descendant · 2 generations on · 19 of its ownK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
- Descendant · 2 generations on · 19 of its ownK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- Descendant · cites it directly · 17 of its ownK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- Descendant · 2 generations on · 10 of its ownK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K062996Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007 · cites it directly32descendants
- K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009 · 2 generations on19descendants
- K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007 · 2 generations on19descendants
- K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc. · 2011 · cites it directly17descendants
- K111597Disposable Stimulating ElectrodeNuvasive, Inc. · 2011 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −1 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| 0 (this device) | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| +1 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| +2 | K090838 | Stimulus/Dissection Instruments | Axon Systems, Inc. | 2009 | — |
| +2 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| +1 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| +2 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 GXZ? 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 GXZ device
- #1 K231691 Phantom XL Insulated Dilatorsscore 10.4 · 7 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 |
|---|---|---|---|
| * | K991583 | Neurosign 400, 4 Channel Motor Nerve MonitorSummary page 1…Name: Disposable probe Classification Name: Needle electrode (21 CFR section 882.1350) Substantial Equivalence: K991583: Neurosign 400, 4 channel motor nerve monitor K980148: Neurosign 800, 8 channel m… | 1999 |
| * | K980148 | Neurosign 800, 8 Channel Motor Nerve MonitorSummary page 1…section 882.1350) Substantial Equivalence: K991583: Neurosign 400, 4 channel motor nerve monitor K980148: Neurosign 800, 8 channel motor nerve monitor K964869: Neurosign 800, 8 channel m… | 1998 |
| * | K964869 | Neurosign 800, 8 Channel Motor Nerve MonitorSummary page 1…eurosign 400, 4 channel motor nerve monitor K980148: Neurosign 800, 8 channel motor nerve monitor K964869: Neurosign 800, 8 channel motor nerve monitor Device description: There are three types of disposable probes… | 1997 |
What descends from it? (38)
See all 384 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062996 | Disposable Monopolar and Bipolar Stimulator Probes | 2007 | 32 |
| K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw… | 2011 | 17 |
| K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal… | 2013 | 3 |
| K100912 | Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator… | 2010 | 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 13 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K062996 (Axon Systems, Inc., 2007) has gone furthest, with 32 descendants of its own.
- 2 other devices also cite its predicate K991583.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXZ
102in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXZ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXZ
75in 2025
MAUDE reports naming product code GXZ, 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 | 102 | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 19 | 4 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 12 |
| 2013 | 2 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 1 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 9 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 2 | — | 0 | 21 |
| 2024 | 1 | — | 0 | 58 |
| 2025 | 0 | — | 0 | 75 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The disposable probe is used:
- to locate and identify cranial motor nerves during ENT and intra-cranial procedures
- to locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots
- to locate, identify and monitor cranial motor nerves during surgery
The motor nerves are monitored by detecting EMG activity in the muscles they innervate
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050325
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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