510(k) · Cleared
ClearedSubdermal Needle Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xian Friendship Electronics Co., Ltd. · GXZ Electrode, Needle
Cleared on May 16, 2008 as substantially equivalent to K050194 (Axon Systems, Inc., 2005) and 2 other predicates after a 275-day review. Its family tree reaches back 4 generations to 1987. 5 later devices descend from it.
- Decided
- May 16, 2008
- Review
- 275 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K870795 (1987). 24 ancestors in all, the oldest K850107 (1985). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
- 3 generations backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- 2 generations backK990015 Electrode NeedlesTechnomed Europe · 1999
- 1 generation backK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
- This deviceK072276 Subdermal Needle ElectrodesXian Friendship Electronics Co., Ltd. · 2008
- Descendant · cites it directly · 3 of its ownK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
- Descendant · cites it directly · 0 of its ownK232581 Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK161566 DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK152984 Disposable Concentric Needle electrodes, Disposable Monopolar Needle…Bio Protech, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe · 2013 · cites it directly3descendants
- K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024 · 2 generations on0descendants
- K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023 · cites it directly0descendants
- K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016 · 2 generations on0descendants
- K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870795 | Emg Electrodes and Extension Cords | Nihon Kohden America, Inc. | 1987 | — |
| −3 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| −2 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| −1 | K022914 | Rhythmlink International Subdermal Needle Electrodes | Rhythmlink International, LLC | 2002 | — |
| 0 (this device) | 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 |
| +2 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
| +1 | K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023 | — |
| +2 | K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | 2016 | — |
| +2 | 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 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K050194 | Axon Systems Subdermal Needle ElectrodesSummary page 1…s Manufacturer: Axon Systems, Inc. Trade Name: Subdermal Needle Electrodes FDA number: K050194 Manufacturer: Rhythmlink International, LLC Trade Name: Rh… | 2005 |
| * | K022914 | Rhythmlink International Subdermal Needle ElectrodesSummary page 1…Trade Name: Rhythmlink International Subdermal Needle Electrodes FDA number: K022914 Section II- 1(verl.0) Manufacturer: Medtronic… | 2002 |
| * | K990375 | Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75Summary page 2…nal Trade Name: Diagnostics A/S Disposable Monopolar Needle Electrodes FDA number: K990375 5. Description of device Xian Friendship Electronics Co., Ltd.s' Subdermal Needle Electrodes are disposable (for "Single Use On… | 1999 |
What descends from it? (5)
2 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 21 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K130136 (Technomed Europe, 2013) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K050194.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
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. The electrodes are sterile and for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072276: 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/K072276
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