510(k) · Cleared
ClearedAxon Systems Subdermal Needle Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Systems, Inc. · GXZ Electrode, Needle
Cleared on Apr 26, 2005 as substantially equivalent to K010019 (Nicolet Biomedical, Inc., 2001) and 2 other predicates after an 89-day review. Its family tree reaches back 3 generations to 1987. 13 later devices descend from it.
- Decided
- Apr 26, 2005
- Review
- 89 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K870795 (1987). 20 ancestors in all, the oldest K850107 (1985). 13 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
- 2 generations backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- 1 generation backK990015 Electrode NeedlesTechnomed Europe · 1999
- This deviceK050194 Axon Systems Subdermal Needle ElectrodesAxon Systems, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK073229 Nerve Monitoring CablePioneer Surgical Technology · 2008
- Descendant · cites it directly · 5 of its ownK072276 Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 4 of its ownK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- Descendant · 3 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K073229Nerve Monitoring CablePioneer Surgical Technology · 2008 · cites it directly5descendants
- K072276Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008 · cites it directly5descendants
- K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015 · 2 generations on4descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on3descendants
- K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870795 | Emg Electrodes and Extension Cords | Nihon Kohden America, Inc. | 1987 | — |
| −2 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| −1 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| 0 (this device) | K050194 | Axon Systems Subdermal Needle Electrodes | Axon Systems, Inc. | 2005 | — |
| +1 | K073229 | Nerve Monitoring Cable | Pioneer Surgical Technology | 2008 | — |
| +1 | K072276 | Subdermal Needle Electrodes | Xian Friendship Electronics Co., Ltd. | 2008 | — |
| +2 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| +3 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +2 | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K010019 | Sterile Subdermal Needle ElectrodesSummary page 1…codes: GXZ Predicate Devices Manufacturer: Nicolet Biomedical Trade Name: Sterile Subdermal Needle Electrodes FDA number: K010019 Manufacturer: TechnoMed Europe Trade Name: Various Needle Electrodes… | 2001 |
| * | K990015 | Electrode NeedlesSummary page 1…FDA number: K010019 Manufacturer: TechnoMed Europe Trade Name: Various Needle Electrodes FDA number: K990015 Manufacturer: Agram Export-import Company Trade Name: Spiral Electrode… | 1999 |
| * | K934779 | Agram Spyral ElectrodeSummary page 1…FDA number: K990015 Manufacturer: Agram Export-import Company Trade Name: Spiral Electrode FDA number: K934779 Appendix J… | 1995 |
What descends from it? (13)
See all 134 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)
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 18 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K073229 (Pioneer Surgical Technology, 2008) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K010019.
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?
Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050194: Axon Systems Subdermal Needle Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050194
Report an extraction error
Are you the manufacturer?
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