FDA product code IKT: Electrode, Needle, Diagnostic Electromyograph
IKT is the FDA product code for electrode, needle, diagnostic electromyograph. It is a Class II device, regulated under 21 CFR 890.1385 and reviewed by the Neurology panel. FDA has cleared 43 510(k) submissions under IKT, 1 in the last five years, from 20 different applicants. The average 510(k) review took 192 days (median 140); 118 days on average over the last three years. FDA has posted 2 recalls for IKT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class II |
| Regulation | 21 CFR 890.1385 |
| Review panel | NE — Neurology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IKT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 283 |
| 2018 | 1 | 196 |
| 2026 | 1 | 118 |
Compare with all 510(k) review times · Search every IKT clearance
Top IKT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chalgren Enterprises, Inc. | 9 | 1999-06-22 |
| Technomed Europe | 3 | 2026-03-15 |
| Natus Manufacturing Limited | 3 | 2018-06-29 |
| Rhythmlink International, LLC | 3 | 2012-06-22 |
| Medicotest A/S | 3 | 2002-06-14 |
15 more applicants have IKT clearances. See the full list in Caduvo.
Most recent IKT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253581 | Technomed Europe | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) | 2026-03-15 | 118 |
| K173815 | Natus Manufacturing Limited | Allergan Botox Needle Electrode | 2018-06-29 | 196 |
| K161430 | Natus Manufacturing Limited | Myoject Luer Lock Needle Electrode | 2017-03-02 | 283 |
| K152984 | Bio Protech, Inc. | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes | 2016-06-03 | 238 |
| K143433 | Natus Manufacturing Limited | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm | 2015-08-28 | 270 |
Recalls for IKT devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-08-09.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code IKT?
IKT is the FDA product code for electrode, needle, diagnostic electromyograph. It is a Class II device, regulated under 21 CFR 890.1385 and reviewed by the Neurology panel.
What device class is IKT?
Class II, regulation 21 CFR 890.1385. Typical premarket route: 510(k).
How long does a 510(k) take for product code IKT?
Across 43 cleared submissions the average was 192 days from receipt to decision (median 140).
Which companies have the most IKT clearances?
Chalgren Enterprises, Inc. (9); Technomed Europe (3); Natus Manufacturing Limited (3); Rhythmlink International, LLC (3); Medicotest A/S (3).
Have IKT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-08-09.
Next steps
- Run an FDA pathway report with predicate devices for product code IKT
- Run a recall and safety report across every IKT manufacturer
- Watch product code IKT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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