510(k) · Cleared
Recalled · Class II · 2022Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · GXZ Electrode, Needle
Cleared on Jul 19, 2013 as substantially equivalent to K990015 (Technomed Europe, 1999) and 4 other predicates after a 182-day review. Its family tree reaches back 5 generations to 1987. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 19, 2013
- Review
- 182 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 5 generations to K870795 (1987). 34 ancestors in all, the oldest K850107 (1985). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
- 4 generations backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- 3 generations backK990015 Electrode NeedlesTechnomed Europe · 1999
- 2 generations backK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
- 1 generation backK072276 Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008
- This deviceK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013
- Descendant · cites it directly · 0 of its ownK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
- Descendant · cites it directly · 0 of its ownK161566 DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK152984 Disposable Concentric Needle electrodes, Disposable Monopolar Needle…Bio Protech, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024 · cites it directly0descendants
- K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016 · cites it directly0descendants
- K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870795 | Emg Electrodes and Extension Cords | Nihon Kohden America, Inc. | 1987 | — |
| −4 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| −3 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| −2 | K022914 | Rhythmlink International Subdermal Needle Electrodes | Rhythmlink International, LLC | 2002 | — |
| −1 | K072276 | Subdermal Needle Electrodes | Xian Friendship Electronics Co., Ltd. | 2008 | — |
| 0 (this device) | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | — |
| +1 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
| +1 | K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | 2016 | — |
| +1 | K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle… | Bio Protech, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (5)
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 |
|---|---|---|---|
| * | K990015 | Electrode NeedlesSummary page 1…and section 890.1385 product code IKT (diagnostic electromyograph needle electrode). Legally Marketed K990015: Technomed Europe Needle Electrodes Predicate Devices: K050325: Technomed Europe Disposable Con… | 1999 |
| * | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar ProbeSummary page 1…dle electrode). Legally Marketed K990015: Technomed Europe Needle Electrodes Predicate Devices: K050325: Technomed Europe Disposable Concentric Probe. Disposable Bipolar Probe, Disposable Monopolar Probe… | 2005 |
| * | K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledSummary page 1…K050325: Technomed Europe Disposable Concentric Probe. Disposable Bipolar Probe, Disposable Monopolar Probe K062437: Technomed Europe Disposable Hypodermic EMG Needle Electrode KI 12034: C… | 2007 |
| * | K112034 | Teca Elite Disposable Concentric NeedlesSummary page 2…isposable needle Subdermal Needle disposable concentric and subdermal needle electrode EEG / ENIG ElectrodeslIK0722761 needles 11<1120341 cecctrodcSlKl30l36l IK9900 151 __________… | 2011 |
| * | K072276 | Subdermal Needle ElectrodesSummary page 1…Electrode KI 12034: Carefusion 209. Inc. TECA T1ELITE Disposable Concentric Needles K072276: Xian Friendship Electronics Co.. Ltd.. Subdermal Needle Electrodes Device description: Need… | 2008 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Aug 9, 2022 | Class II | Z-1737-2022 | Labeling Change Control | Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. |
| Dec 8, 2021 | Class II | Z-0465-2022 | Device Design | There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K241045 (Technomed Europe, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K990015.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
Needle Electrodes for Neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130136 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130136
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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