FDA product code IKD: Cable, Electrode
IKD is the FDA product code for cable, electrode. It is a Class II device, regulated under 21 CFR 890.1175 and reviewed by the Physical Medicine panel. FDA has cleared 6 510(k) submissions under IKD, from 6 different applicants. The average 510(k) review took 58 days (median 58). FDA has posted 11 recalls for IKD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cable, Electrode |
| Device class | Class II |
| Regulation | 21 CFR 890.1175 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IKD clearance
Top IKD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oscor, Inc. | 1 | 2007-06-07 |
| Therapy Equipment, Inc. | 1 | 1999-10-13 |
| Physiometrix, Inc. | 1 | 1993-12-23 |
| Chemfet Corp. | 1 | 1987-11-09 |
| Quinton, Inc. | 1 | 1984-01-30 |
1 more applicants have IKD clearances. See the full list in Caduvo.
Most recent IKD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070926 | Oscor, Inc. | ELECTRODE/EXTENSION CABLES, MODELS ATAR | 2007-06-07 | 65 |
| K992372 | Therapy Equipment, Inc. | THE LEADAWAY | 1999-10-13 | 90 |
| K935260 | Physiometrix, Inc. | PHYSIOMETRIX CABLE ADAPTER MODIFICATION | 1993-12-23 | 51 |
| K873361 | Chemfet Corp. | LIFE-SPAN CABLE | 1987-11-09 | 80 |
| K834583 | Quinton, Inc. | CLEAR LEADS-RADIOTRANSPARENT WIRES | 1984-01-30 | 32 |
Recalls for IKD devices
11 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-07-02.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 1 |
| 2021 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code IKD?
IKD is the FDA product code for cable, electrode. It is a Class II device, regulated under 21 CFR 890.1175 and reviewed by the Physical Medicine panel.
What device class is IKD?
Class II, regulation 21 CFR 890.1175. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IKD?
Across 6 cleared submissions the average was 58 days from receipt to decision (median 58).
Which companies have the most IKD clearances?
Oscor, Inc. (1); Therapy Equipment, Inc. (1); Physiometrix, Inc. (1); Chemfet Corp. (1); Quinton, Inc. (1).
Have IKD devices been recalled?
Yes: 11 product recalls across 8 recall events; the most recent began 2024-07-02.
Next steps
- Run an FDA pathway report with predicate devices for product code IKD
- Run a recall and safety report across every IKD manufacturer
- Watch product code IKD 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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