FDA product code IKN: Electromyograph, Diagnostic
IKN is the FDA product code for electromyograph, diagnostic. It is a Class II device, regulated under 21 CFR 890.1375 and reviewed by the Neurology panel. FDA has cleared 75 510(k) submissions under IKN, from 56 different applicants. The average 510(k) review took 139 days (median 87). FDA has posted 1 recall for IKN devices.
Classification
| Field | Value |
|---|---|
| Device name | Electromyograph, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 890.1375 |
| 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 IKN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 178 |
Compare with all 510(k) review times · Search every IKN clearance
Top IKN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nicolet Biomedical Instruments | 6 | 1988-03-22 |
| Fasstech | 3 | 2007-08-16 |
| Teca, Inc. | 3 | 1981-10-13 |
| Dorsavi, Ltd. | 2 | 2017-07-14 |
| Excel Tech. , Ltd. | 2 | 2005-10-28 |
51 more applicants have IKN clearances. See the full list in Caduvo.
Most recent IKN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172743 | Natus Neurology Incorporated | Natus VikingQuest | 2017-12-19 | 98 |
| K163150 | Dorsavi, Ltd. | ViMove2 | 2017-07-14 | 247 |
| K162383 | Cadwell Industries, Inc. | Cadwell Sierra Summit, Cadwell Sierra Ascent | 2017-03-01 | 188 |
| K142494 | Dorsavi, Ltd. | ViMove | 2015-05-28 | 265 |
| K131094 | Dorsa VI Pty., Ltd. | VIMOVE | 2014-07-11 | 449 |
Recalls for IKN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-01-29.
Frequently asked questions
What is FDA product code IKN?
IKN is the FDA product code for electromyograph, diagnostic. It is a Class II device, regulated under 21 CFR 890.1375 and reviewed by the Neurology panel.
What device class is IKN?
Class II, regulation 21 CFR 890.1375. Typical premarket route: 510(k).
How long does a 510(k) take for product code IKN?
Across 75 cleared submissions the average was 139 days from receipt to decision (median 87).
Which companies have the most IKN clearances?
Nicolet Biomedical Instruments (6); Fasstech (3); Teca, Inc. (3); Dorsavi, Ltd. (2); Excel Tech. , Ltd. (2).
Have IKN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-01-29.
Next steps
- Run an FDA pathway report with predicate devices for product code IKN
- Run a recall and safety report across every IKN manufacturer
- Watch product code IKN 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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