510(k) · Cleared
ClearedTeca Myoject Disposable Needle Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medelec, Inc. D.B.A. Teca Corp. · IKT Electrode, Needle, Diagnostic Electromyograph
Cleared on Nov 20, 1997 after a 70-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Nov 20, 1997
- Review
- 70 days
- Class
- Class II
- Product code
- IKT
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 6 citing it directly.
- This deviceK973444 Teca Myoject Disposable Needle ElectrodesMedelec, Inc. D.B.A. Teca Corp. · 1997
- Descendant · cites it directly · 6 of its ownK062437 Disposable Hypodermic Emg Needle Electrode Technomed Europe Version…Technomed Europe · 2007
- Descendant · 2 generations on · 3 of its ownK130136 Disposable and Reusable Concentric Needle Electrodes,Disposable and…Technomed Europe · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK091410 Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 2009
- Descendant · 2 generations on · 1 of its ownK092973 Disposable and Reusable Concentric Needles / Disposable and Reusable…Bionen S.A.S. · 2010
- Descendant · 3 generations on · 0 of its ownK241045 Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062437Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledTechnomed Europe · 2007 · cites it directly6descendants
- K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…Technomed Europe · 2013 · 2 generations on3descendants
- K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 2009 · cites it directly2descendants
- K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleBionen S.A.S. · 2010 · 2 generations on1descendant
- K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973444 | Teca Myoject Disposable Needle Electrodes | Medelec, Inc. D.B.A. Teca Corp. | 1997 | — |
| +1 | K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and… | Technomed Europe | 2007 | — |
| +2 | K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable… | Technomed Europe | 2013 | 2 |
| +1 | K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, | Spes Medica Srl | 2009 | — |
| +2 | K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar… | Bionen S.A.S. | 2010 | — |
| +3 | K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled | 2007 | 6 |
| K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, | 2009 | 2 |
| K173815 | Allergan Botox Needle Electrode | 2018 | 0 |
| K161430 | Myoject Luer Lock Needle Electrode | 2017 | 0 |
| K093825 | Ambu Neuroline Disposable Inoject Needle Electrode | 2010 | 0 |
| K990793 | Accuguide Muscle Injection Monitor | 1999 | 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?
- Of its descendants, K062437 (Technomed Europe, 2007) has gone furthest, with 6 descendants 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 | — |
What is it indicated for?
The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to hléetfanelechode, infl\efomofapmbe, mbapaflentblomlea patticular muscle and then inject a medication into that muscle. The hypodetmicmedlewifllanopm!umenisdesignedformusde stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
Note: TECA Corp. does not supply any drugs with needle electrodes nor does TECA Corp. offer for sale any form of drugs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973444: Teca Myoject Disposable Needle Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973444
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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