510(k) · Cleared
ClearedDisposable Concentric Needle Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chalgren Enterprises, Inc. · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Feb 12, 1993 after a 157-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 12, 1993
- Review
- 157 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK924521 Disposable Concentric Needle ElectrodeChalgren Enterprises, Inc. · 1993
- Descendant · cites it directly · 1 of its ownK011818 Sterile Emg ElectrodesNicolet Biomedical, Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK111131 Teca (TM) Elite Disposable Monopolar NeedlesCarefusion 209, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK080914 Ultrasharp Concentric NeedlesRochester Electro Medical, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K011818Sterile Emg ElectrodesNicolet Biomedical, Inc. · 2001 · cites it directly1descendant
- K111131Teca (TM) Elite Disposable Monopolar NeedlesCarefusion 209, Inc. · 2011 · 2 generations on0descendants
- K080914Ultrasharp Concentric NeedlesRochester Electro Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924521 | Disposable Concentric Needle Electrode | Chalgren Enterprises, Inc. | 1993 | — |
| +1 | K011818 | Sterile Emg Electrodes | Nicolet Biomedical, Inc. | 2001 | — |
| +2 | K111131 | Teca (TM) Elite Disposable Monopolar Needles | Carefusion 209, Inc. | 2011 | — |
| +1 | K080914 | Ultrasharp Concentric Needles | Rochester Electro Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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?
- Of its descendants, K011818 (Nicolet Biomedical, Inc., 2001) has gone furthest, with 1 descendant 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/K924521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924521: Disposable Concentric Needle Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924521
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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