510(k) · Cleared
ClearedUniversal Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurometrix, Inc. · GXY Electrode, Cutaneous
Cleared on Jan 21, 2009 as substantially equivalent to K081871 (Neurometrix, Inc., 2008) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 1980.
- Decided
- Jan 21, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K802637 (1980). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK802637 Teca Model-10 ElectromyographTeca, Inc. · 1980
- 5 generations backK982359 NC-StatNeurometrix, Inc. · 1998
- 4 generations backK013459 Modification of NC-StatNeurometrix, Inc. · 2002
- 3 generations backK041320 Modification to NC-StatNeurometrix, Inc. · 2004
- 2 generations backK060584 NC-StatNeurometrix, Inc. · 2006
- 1 generation backK081871 Universal ElectrodesNeurometrix, Inc. · 2008
- This deviceK083818 Universal ElectrodesNeurometrix, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K802637 | Teca Model-10 Electromyograph | Teca, Inc. | 1980 | — |
| −5 | K982359 | NC-Stat | Neurometrix, Inc. | 1998 | — |
| −4 | K013459 | Modification of NC-Stat | Neurometrix, Inc. | 2002 | — |
| −3 | K041320 | Modification to NC-Stat | Neurometrix, Inc. | 2004 | — |
| −2 | K060584 | NC-Stat | Neurometrix, Inc. | 2006 | — |
| −1 | K081871 | Universal Electrodes | Neurometrix, Inc. | 2008 | — |
| 0 (this device) | K083818 | Universal Electrodes | Neurometrix, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K081871 | Universal ElectrodesSummary page 1…th leads and connector Classification Name 882 1320 GXY Electrode, Cutaneous 3 PREDICATE DEVICES * NeuroMetrix UNIVERSAL Electrodes (K081871) * NeuroMetrix Biosensors (K060584) 4 INTENDED USE The NeuroMetrix UNIVERSAL Electrodes are intended f… | 2008 |
| * | K060584 | NC-StatSummary page 1…Name 882 1320 GXY Electrode, Cutaneous 3 PREDICATE DEVICES * NeuroMetrix UNIVERSAL Electrodes (K081871) * NeuroMetrix Biosensors (K060584) 4 INTENDED USE The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipmen… | 2006 |
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 29 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
The NeuroMetnx UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are non-sterile and are for single patient use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083818: Universal Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083818
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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