510(k) · Cleared
ClearedTeca NCS Electrode System 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medelec, Inc. D.B.A. Teca Corp. · GXY Electrode, Cutaneous
Cleared on Mar 26, 1998 after a 307-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Mar 26, 1998
- Review
- 307 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK971914 Teca NCS Electrode System 2000Medelec, Inc. D.B.A. Teca Corp. · 1998
- Descendant · cites it directly · 6 of its ownK062198 Sunspots Pre-Gelled Surface ElectrodesAxon Systems, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK110289 Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK073532 Disposable Adhesive Surface Electrodes, Disc ElectrodesTechnomed Europe · 2008
- Descendant · 3 generations on · 1 of its ownK142159 Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK081871 Universal ElectrodesNeurometrix, Inc. · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K062198Sunspots Pre-Gelled Surface ElectrodesAxon Systems, Inc. · 2006 · cites it directly6descendants
- K110289Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011 · 2 generations on2descendants
- K073532Disposable Adhesive Surface Electrodes, Disc ElectrodesTechnomed Europe · 2008 · cites it directly2descendants
- K142159Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015 · 3 generations on1descendant
- K081871Universal ElectrodesNeurometrix, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971914 | Teca NCS Electrode System 2000 | Medelec, Inc. D.B.A. Teca Corp. | 1998 | — |
| +1 | K062198 | Sunspots Pre-Gelled Surface Electrodes | Axon Systems, Inc. | 2006 | — |
| +2 | K110289 | Friendship Medical Disposable Pre-Gelled AG / Agcl Surface Electrode | Xian Friendship Medical Electronics Co., Ltd. | 2011 | — |
| +1 | K073532 | Disposable Adhesive Surface Electrodes, Disc Electrodes | Technomed Europe | 2008 | — |
| +3 | K142159 | Disposable Pre-Gelled Surface Electrode | Rochester Electro Medical, Inc. | 2015 | — |
| +2 | K081871 | Universal Electrodes | Neurometrix, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K062198 (Axon Systems, Inc., 2006) has gone furthest, with 6 descendants of its own.
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?
The NCS Electrode System 2000 is for electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971914 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971914: Teca NCS Electrode System 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971914
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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