510(k) · Cleared
ClearedTeca (TM) Elite Disposable Monopolar 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 Jun 17, 2011 as substantially equivalent to K011818 (Nicolet Biomedical, Inc., 2001) after a 57-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jun 17, 2011
- Review
- 57 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850107 (1985). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850107 | Concentric Needle Electrodes-Various Sizes W/Conne | Nicolet Biomedical Instruments | 1985 | — |
| −1 | K011818 | Sterile Emg Electrodes | Nicolet Biomedical, Inc. | 2001 | — |
| 0 (this device) | K111131 | Teca (TM) Elite Disposable Monopolar Needles | Carefusion 209, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K011818 | Sterile Emg ElectrodesSummary page 1…sion 510(k) Predicate Equivalent Devices: Model Number Manufacturer/Model TECATM elite K0 11818 Nicolet Biomedical, Inc.(now Disposable Monopolar owned by CareFusion) / Sterile… | 2001 |
| † | K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle | 2010 |
| † | K093109 | Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5') | 2010 |
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- None of the 7 ancestors has a recall.
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?
TECATM1 elite Disposable Monopolar 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/K111131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111131: Teca (TM) Elite Disposable Monopolar Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111131
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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