510(k) · Cleared
ClearedMedical Disposable Sterile Needle Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Haishen Medical Device Associates Co., Ltd. · GXZ Electrode, Needle
Cleared on Dec 4, 2023 as substantially equivalent to K072276 (Xian Friendship Electronics Co., Ltd., 2008) after a 101-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Dec 4, 2023
- Review
- 101 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K870795 (1987). 25 ancestors in all, the oldest K850107 (1985). No later device cites it as a predicate yet.
- 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 deviceK232581 Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023
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) | K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K072276 | Subdermal Needle ElectrodesSummary page 5…edle Electrode Classification Name: Needle Electrode Regulatory Class: II Product Code: GXZ IV. PREDICATE DEVICE Product Name: Subdermal Needle Electrodes 510(k) Number: K072276 Product Code: GXZ Manufacture: Xian Friendship Electronics Co., Ltd. V. DEVICE DESCRIPTION Medical disposable sterile needle elec… | 2008 |
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 36 years and passes through 6 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 25 ancestors have a recall of any class.
- 1 other device also cites its predicate K072276.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232581: Medical Disposable Sterile Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232581
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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