510(k) · Cleared
ClearedSle Electrodes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialized Laboratory Equipment, Ltd. · GXY Electrode, Cutaneous
Cleared on Oct 22, 1998 as substantially equivalent to K931430 (Medicotest, Inc., 1993) and 1 other predicate after a 261-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Oct 22, 1998
- Review
- 261 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931430 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK931430 Cutaneous ElectrodeMedicotest, Inc. · 1993
- This deviceK980410 Sle Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931430 | Cutaneous Electrode | Medicotest, Inc. | 1993 | — |
| 0 (this device) | K980410 | Sle Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 GXY? 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 GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K760213 | FDA’s K760213 is Lenses, Contact, Polymethyl Methacrylate Our OCR of the scanned summary read K760213, FDA’s number for Lenses, Contact, Polymethyl Methacrylate (Progressive Affiliated Labs, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Electrode, PNS, NDM Corp.”. Kept off the family tree. Summary page 1…electrode, stick-on electrode, etc. Proprietary Name: SLE Electrodes and Accessories Classitication Number: BOGXY Substantial Equivalence: Electrode, PNS, NDM Corp. (K760213), Cutaneous Electrode, Medicotest, Inc, (K931430), Electrode, Cutaneous, Cadwell Laboratories, Inc. (K933801), and others. Devi… | 1976 |
| * | K931430 | Cutaneous ElectrodeSummary page 1…Name: SLE Electrodes and Accessories Classitication Number: BOGXY Substantial Equivalence: Electrode, PNS, NDM Corp. (K760213), Cutaneous Electrode, Medicotest, Inc, (K931430), Electrode, Cutaneous, Cadwell Laboratories, Inc. (K933801), and others. Device Description: The SLE Electrodes and Accessorie… | 1993 |
| * | K933801 | Electrode, CutaneousSummary page 1…BOGXY Substantial Equivalence: Electrode, PNS, NDM Corp. (K760213), Cutaneous Electrode, Medicotest, Inc, (K931430), Electrode, Cutaneous, Cadwell Laboratories, Inc. (K933801), and others. Device Description: The SLE Electrodes and Accessories device is a cutaneous electrode. Intended Use: The SLE Ele… | 1994 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K931430.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, 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 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
SLE Electrodes and Accessories are intended to be used applied directly to a patient's skin to record physiological gignals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.
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/K980410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980410: Sle Electrodes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980410
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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