510(k) · Cleared
ClearedEmg Electrodes and Extension Cords
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Mar 13, 1987 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.
- Decided
- Mar 13, 1987
- Review
- 15 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 0
57 later devices descend from it, 1 citing it directly.
- This deviceK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
- Descendant · cites it directly · 56 of its ownK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- Descendant · 2 generations on · 55 of its ownK990015 Electrode NeedlesTechnomed Europe · 1999
- Descendant · 3 generations on · 50 of its ownK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
- Descendant · 4 generations on · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- Descendant · 5 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K981004Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998 · cites it directly56descendants
- K990015Electrode NeedlesTechnomed Europe · 1999 · 2 generations on55descendants
- K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002 · 3 generations on50descendants
- K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · 4 generations on35descendants
- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 5 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K870795 | Emg Electrodes and Extension Cords | Nihon Kohden America, Inc. | 1987 | — |
| +1 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| +2 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| +3 | K022914 | Rhythmlink International Subdermal Needle Electrodes | Rhythmlink International, LLC | 2002 | — |
| +4 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| +5 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IKT? 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 IKT device
- #1 K253581 Disposable Concentric Needle Electrode…score 11.6 · 3 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981004 | Sle Emg Electrodes and Accessories | 1998 | 56 |
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, K981004 (Specialized Laboratory Equipment, Ltd., 1998) has gone furthest, with 56 descendants of its own.
How does its category compare?
All IKT devicesIKT Electrode, Needle, Diagnostic Electromyograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKT
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · IKT
71in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKT
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKT
3in 2025
MAUDE reports naming product code IKT, 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 | 2 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 3 | 71 | 0 | 7 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 8 |
| 2018 | 1 | — | 0 | 25 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K870795 · printed Nov 4, 2026
Cite this page
510(k) Report. “K870795: Emg Electrodes and Extension Cords.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870795
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026