510(k) · Cleared
ClearedNeuroline, Disposable Concentric Needle Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicotest A/S · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Nov 20, 1997 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 60 later devices descend from it.
- Decided
- Nov 20, 1997
- Review
- 63 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 5 citing it directly.
- This deviceK973529 Neuroline, Disposable Concentric Needle ElectrodesMedicotest A/S · 1997
- Descendant · cites it directly · 56 of its ownK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- Descendant · cites it directly · 55 of its ownK990015 Electrode NeedlesTechnomed Europe · 1999
- Descendant · 2 generations on · 50 of its ownK022914 Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002
- Descendant · 3 generations on · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- Descendant · 4 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K981004Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998 · cites it directly56descendants
- K990015Electrode NeedlesTechnomed Europe · 1999 · cites it directly55descendants
- K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 2002 · 2 generations on50descendants
- K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · 3 generations on35descendants
- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 4 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973529 | Neuroline, Disposable Concentric Needle Electrodes | Medicotest A/S | 1997 | — |
| +1 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| +1 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| +2 | K022914 | Rhythmlink International Subdermal Needle Electrodes | Rhythmlink International, LLC | 2002 | — |
| +3 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| +4 | 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 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 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), 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 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (60)
See all 605 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, 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 | — |
What is it indicated for?
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
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/K973529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973529: Neuroline, Disposable Concentric Needle Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973529
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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