510(k) · Cleared
ClearedDisposable Subdermal Needle Electrode, Corkscrew
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technomed Europe · GXZ Electrode, Needle
Cleared on Dec 11, 2024 as substantially equivalent to K130136 (Technomed Europe, 2013) after a 238-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Dec 11, 2024
- Review
- 238 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K870795 (1987). 35 ancestors in all, the oldest K850107 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
- 5 generations backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- 4 generations backK990015 Electrode NeedlesTechnomed Europe · 1999
- 3 generations backK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
- 2 generations backK072276 Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008
- 1 generation backK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
- This deviceK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870795 | Emg Electrodes and Extension Cords | Nihon Kohden America, Inc. | 1987 | — |
| −5 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| −4 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| −3 | K022914 | Rhythmlink International Subdermal Needle Electrodes | Rhythmlink International, LLC | 2002 | — |
| −2 | K072276 | Subdermal Needle Electrodes | Xian Friendship Electronics Co., Ltd. | 2008 | — |
| −1 | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | 2 |
| 0 (this device) | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Summary page 5…osable Subdermal Corkscrew Needle Electrode Classification 21 C.F.R. § 882.1350, Needle Electrode, Class II, product code GXZ and IKT Predicate Devices K130136 Disposable Monopolar Needle Electrode and Disposable Subdermal Needle Electrode, 21 C.F.R. § 882.1350, GXZ and IKT. Devi… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 4 of the 35 ancestors have a recall of any class.
- 2 other devices also cite its predicate K130136.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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/K241045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241045: Disposable Subdermal Needle Electrode, Corkscrew.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241045
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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