510(k) · Cleared
ClearedRhythmlink Disposable Monopolar Emg Needle, Model TFDN26032252R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhythmlink International, LLC · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Jun 23, 2009 as substantially equivalent to K071185 (Ambu A/S, 2007) after a 71-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Jun 23, 2009
- Review
- 71 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071185 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK071185 Modification to: Ambu Neuroline, Disposable Monopolar Needle ElectrodeAmbu A/S · 2007
- This deviceK091056 Rhythmlink Disposable Monopolar Emg Needle, Model TFDN26032252RRhythmlink International, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071185 | Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode | Ambu A/S | 2007 | — |
| 0 (this device) | K091056 | Rhythmlink Disposable Monopolar Emg Needle, Model TFDN26032252R | Rhythmlink International, LLC | 2009 | — |
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? (1)
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…ograph Needle Electrode This device has not been previously submitted to the FDA. Predicate Device(s): 5 10(k) Number: K071185 Manufacturer: Ambu® Trade Name: Neuroline Disposable Monopo… | 2007 |
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?
- Its one ancestor has no 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. 2009, 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?
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091056: Rhythmlink Disposable Monopolar Emg Needle, Model TFDN26032252R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091056
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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