510(k) · Cleared
ClearedDisposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionen S.A.S. · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Oct 7, 2010 as substantially equivalent to K071186 (Ambu A/S, 2007) and 4 other predicates after a 377-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Oct 7, 2010
- Review
- 377 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K870795 (1987). 30 ancestors in all, the oldest K850107 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK870795 Emg Electrodes and Extension CordsNihon Kohden America, Inc. · 1987
- 3 generations backK981004 Sle Emg Electrodes and AccessoriesSpecialized Laboratory Equipment, Ltd. · 1998
- 2 generations backK990015 Electrode NeedlesTechnomed Europe · 1999
- 1 generation backK050194 Axon Systems Subdermal Needle ElectrodesAxon Systems, Inc. · 2005
- This deviceK092973 Disposable and Reusable Concentric Needles / Disposable and Reusable…Bionen S.A.S. · 2010
- Descendant · cites it directly · 0 of its ownK152984 Disposable Concentric Needle electrodes, Disposable Monopolar Needle…Bio Protech, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870795 | Emg Electrodes and Extension Cords | Nihon Kohden America, Inc. | 1987 | — |
| −3 | K981004 | Sle Emg Electrodes and Accessories | Specialized Laboratory Equipment, Ltd. | 1998 | — |
| −2 | K990015 | Electrode Needles | Technomed Europe | 1999 | — |
| −1 | K050194 | Axon Systems Subdermal Needle Electrodes | Axon Systems, Inc. | 2005 | — |
| 0 (this device) | K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar… | Bionen S.A.S. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K071186 | Modification to: Ambu Neuroline Concentric Needle ElectrodeSummary page 1…r jTrade or Proprietary or Model Name Manufacturer Concentric Needle Electrode K071186 Neuroline, Disposable Concentric needle Ambu A/S electrode… | 2007 |
| * | K931966 | Dantec Disposable Concentric NeedleSummary page 1…Neuroline, Disposable Concentric needle Ambu A/S electrode __________ K931966 Needle electrode EMIG Alpine Biomned… | 1994 |
| * | K050194 | Axon Systems Subdermal Needle ElectrodesSummary page 1…Monopolar/Subdermal Needle Electrode ________ ISubdermal Needle Electrodes, Twisted Pair Ne~edle I K050194 _____Electrodes, Corkscrew (spiral) Needle Electrode I Axon Systems, Inc.… | 2005 |
| * | K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Summary page 7…BIONEN s.a.s. Spes Medica Technomed Europe SIOK number K092973 K091410 K062437 Device class Class 11 Class II… | 2009 |
| * | K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledSummary page 7…Spes Medica Technomed Europe SIOK number K092973 K091410 K062437 Device class Class 11 Class II Class 11 Product code… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes… | 2016 | 0 |
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?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K152984 (Bio Protech, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071186.
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?
The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar/Subdermal Needle electrodes are sterile electrodes indicated for recording muscle activity for Electro-myography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.
The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulinum Toxin while recording muscle activity with Electroymyography (EMG) applications. The electrodes are for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092973
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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