510(k) · Cleared
ClearedIsurg Disposable Subdermal Needle Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isurgical · GXZ Electrode, Needle
Cleared on May 21, 2004 as substantially equivalent to K990015 (Technomed Europe, 1999) and 2 other predicates after a 72-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- May 21, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K870795 (1987). 20 ancestors in all, the oldest K850107 (1985). No later device cites it as a predicate yet.
- 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 deviceK040639 Isurg Disposable Subdermal Needle ElectrodeIsurgical · 2004
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) | K040639 | Isurg Disposable Subdermal Needle Electrode | Isurgical | 2004 | — |
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 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K990015 | Electrode NeedlesSummary page 1…n Leiser, Owner 847-949-9744 847-949-4934 [Surg Disposable Subdermal Needle Electrodes Needle Electrodes Electrode, Needle (per 21 CFR section 882.1350) Class II GXZ K990015 Technomed Europe Technomed EEG/EMG Needlc Electrodes GXZ K010019 Nicolet Biomedical, Incorporated Stenle Subdermal Needle Ele… | 1999 |
| * | K010019 | Sterile Subdermal Needle ElectrodesSummary page 1…l Needle Electrodes Needle Electrodes Electrode, Needle (per 21 CFR section 882.1350) Class II GXZ K990015 Technomed Europe Technomed EEG/EMG Needlc Electrodes GXZ K010019 Nicolet Biomedical, Incorporated Stenle Subdermal Needle Electrodes GXZ K022914 Rhythmlink International, LLC Rhythmlink Inter… | 2001 |
| * | K022914 | Rhythmlink International Subdermal Needle ElectrodesSummary page 1…350) Class II GXZ K990015 Technomed Europe Technomed EEG/EMG Needlc Electrodes GXZ K010019 Nicolet Biomedical, Incorporated Stenle Subdermal Needle Electrodes GXZ K022914 Rhythmlink International, LLC Rhythmlink International Subdermal Needle Electrodes GXZ Summary, Page 1… | 2002 |
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 17 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 20 ancestors have a recall of any class.
- 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.
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?
ISurg Disposable Subdermal Needle Electrodes are intended for use with monitoring, recording and electrical stimulation equipment specifically designed for the recording of biopotential signals from electroencephagraphy (EEG), electromyography (EMG) and nerve potential studies. ISurg Disposable Subdermal Needle Electrodes are "Rx Only", intended for "Single Use Only" and "Sterile".
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040639 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040639: Isurg Disposable Subdermal Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040639
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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