510(k) · Cleared
ClearedAmbu Neuroline Disposable Inoject 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 Jan 13, 2010 as substantially equivalent to K071185 (Ambu A/S, 2007) and 3 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 13, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K973444 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK973444 Teca Myoject Disposable Needle ElectrodesMedelec, Inc. D.B.A. Teca Corp. · 1997
- This deviceK093825 Ambu Neuroline Disposable Inoject Needle ElectrodeAmbu A/S · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973444 | Teca Myoject Disposable Needle Electrodes | Medelec, Inc. D.B.A. Teca Corp. | 1997 | — |
| 0 (this device) | K093825 | Ambu Neuroline Disposable Inoject Needle Electrode | Ambu A/S | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 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? (4)
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 |
|---|---|---|---|
| * | K071185 | Modification to: Ambu Neuroline, Disposable Monopolar Needle ElectrodeSummary page 1…510k Produc number od Amnbu A/S Ambu Neuroline Monopolar needle K071185 GXZ electrode Ambu A/S Ambu Neuroline [noject needle K00 1869 IKT… | 2007 |
| * | K001869 | Diagnostic Electromyography Needle Electrode, Disposable Hypodermic NeedleSummary page 1…A/S Ambu Neuroline Monopolar needle K071185 GXZ electrode Ambu A/S Ambu Neuroline [noject needle K00 1869 IKT electrode Viasys Healthcare TECA Disposable MyoJect Needle K973444 IKT Inc.… | 2000 |
| * | K973444 | Teca Myoject Disposable Needle ElectrodesSummary page 1…/S Ambu Neuroline [noject needle K00 1869 IKT electrode Viasys Healthcare TECA Disposable MyoJect Needle K973444 IKT Inc. Electrodes Alpine Biorned Go-Jeca Needles K002992 IKT… | 1997 |
| * | K002992 | Disposable Hypodermic Needle Electrode, Model…Summary page 1…Healthcare TECA Disposable MyoJect Needle K973444 IKT Inc. Electrodes Alpine Biorned Go-Jeca Needles K002992 IKT 8. Description of device The Ambu Neuroline Disposable Inoject needle electrode is a Single Patient… | 2001 |
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?
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K071185.
How does its category compare?
All IKT devicesIKT Electrode, Needle, Diagnostic Electromyograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy. and nerve block procedures.
For single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093825 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093825: Ambu Neuroline Disposable Inoject Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093825
Report an extraction error
Are you the manufacturer?
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