510(k) · Cleared
ClearedModification to: Ambu Neuroline Concentric Needle Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu A/S · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Jul 30, 2007 as substantially equivalent to K973529 (Medicotest A/S, 1997) and 2 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Jul 30, 2007
- Review
- 91 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931966 (1994). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931966 Dantec Disposable Concentric NeedleDantec Medical, Inc. · 1994
- This deviceK071186 Modification to: Ambu Neuroline Concentric Needle ElectrodeAmbu A/S · 2007
- Descendant · cites it directly · 2 of its ownK091410 Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 2009
- Descendant · cites it directly · 1 of its ownK092973 Disposable and Reusable Concentric Needles / Disposable and Reusable…Bionen S.A.S. · 2010
- Descendant · 2 generations on · 0 of its ownK152984 Disposable Concentric Needle electrodes, Disposable Monopolar Needle…Bio Protech, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 2009 · cites it directly2descendants
- K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S. · 2010 · cites it directly1descendant
- K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931966 | Dantec Disposable Concentric Needle | Dantec Medical, Inc. | 1994 | — |
| 0 (this device) | K071186 | Modification to: Ambu Neuroline Concentric Needle Electrode | Ambu A/S | 2007 | — |
| +1 | K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, | Spes Medica Srl | 2009 | — |
| +1 | K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar… | Bionen S.A.S. | 2010 | — |
| +2 | K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle… | Bio Protech, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973529 | Neuroline, Disposable Concentric Needle ElectrodesSummary page 1…claimed Manufacturer Trade Name 510k number Product code Arnbu A/S Neuroline, Disposable K973529 IKT Concentric needle electrode… | 1997 |
| * | K961013 | Disposable Needle ElectrodeSummary page 1…IKT Concentric needle electrode Viasys H-ealthcare Medelec Elite Dispos- K961013 I KT Inc. able Concentric Needle Electrode… | 1996 |
| * | K931966 | Dantec Disposable Concentric NeedleSummary page 1…Inc. able Concentric Needle Electrode Medtronic Inc. DCNtm Disposable K931966 IKT Concentric Needle Electrode… | 1994 |
What descends from it? (3)
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?
How does its category compare?
All IKT devicesIKT Electrode, Needle, Diagnostic Electromyograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071186 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071186: Modification to: Ambu Neuroline Concentric Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071186
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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