510(k) · Cleared
ClearedTeca Elite Disposable Concentric Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 209, Inc. · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Aug 12, 2011 as substantially equivalent to K961013 (Medelec Intl. Corp., 1996) after a 28-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.
- Decided
- Aug 12, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961013 (1996). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961013 Disposable Needle ElectrodeMedelec Intl. Corp. · 1996
- This deviceK112034 Teca Elite Disposable Concentric NeedlesCarefusion 209, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
- Descendant · 2 generations on · 0 of its ownK161566 DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK152984 Disposable Concentric Needle electrodes, Disposable Monopolar Needle…Bio Protech, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK143433 Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN…Natus Manufacturing Limited · 2015
Most influential descendants
Showing 5 of 5 · See all- K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe · 2013 · cites it directly3descendants
- K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024 · 2 generations on0descendants
- K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016 · 2 generations on0descendants
- K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…Bio Protech, Inc. · 2016 · 2 generations on0descendants
- K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…Natus Manufacturing Limited · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961013 | Disposable Needle Electrode | Medelec Intl. Corp. | 1996 | — |
| 0 (this device) | K112034 | Teca Elite Disposable Concentric Needles | Carefusion 209, Inc. | 2011 | — |
| +1 | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | 2 |
| +2 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
| +2 | K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | 2016 | — |
| +2 | K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle… | Bio Protech, Inc. | 2016 | — |
| +1 | K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable… | Natus Manufacturing Limited | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K961013 | Disposable Needle ElectrodeSummary page 1…Si 0(k) Predicate Equivalent Devices: Mlodel Nfumber Manufacturer /Model TECA TM ELITE K961013 Medelec, -imnited (now owned Disposable Concentric by CareFusion) / Disposable… | 1996 |
| † | K991522 | Microtargeting Electrode | 2000 |
| † | K033173 | Micro Targeting Electrode | 2004 |
| † | K113001 | TECA elite Disposable Monopolar Needles |
What descends from it? (5)
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. 2011, 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?
TECATM ELITE Disposable Concentric Needles are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMO) and nerve potential signals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112034: Teca Elite Disposable Concentric Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112034
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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