510(k) · Cleared
ClearedSpes Medica Subdermal Needle Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spes Medica Srl · GXZ Electrode, Needle
Cleared on Nov 22, 2019 as substantially equivalent to K022914 (Rhythmlink International, LLC, 2002) after a 63-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Nov 22, 2019
- Review
- 63 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- None
- Predicates
- 1
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 deviceK192603 Spes Medica Subdermal Needle ElectrodesSpes Medica Srl · 2019
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) | K192603 | Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 2019 | — |
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? (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 |
|---|---|---|---|
| * | K022914 | Rhythmlink International Subdermal Needle ElectrodesSummary page 4…roduct Code: GXZ Classification Regulation: 882.1350 Predicate Device: Rhythmlink International Subdermal Needle Electrodes (K022914) Device Description: Spes Medica Subdermal Needle Electrodes are monopolar needles intented to use… | 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 32 years and passes through 5 companies; a new generation was cleared every 11.6 years on median.
- 2 of the 20 ancestors have a recall of any class.
- 7 other devices also cite its predicate K022914.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Spes Medica Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192603: Spes Medica 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/K192603
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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