FDA product code IKO: Hammer, Reflex, Powered
IKO is the FDA product code for hammer, reflex, powered. It is a Class II device, regulated under 21 CFR 890.1450 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under IKO. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Hammer, Reflex, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.1450 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IKO clearance
Top IKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Dynamics, Inc. | 1 | 1990-10-30 |
Most recent IKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904113 | Medical Dynamics, Inc. | OPERATIVE RECORDING CAMERA | 1990-10-30 | 54 |
Recalls for IKO devices
openFDA lists no recalls for product code IKO.
Frequently asked questions
What is FDA product code IKO?
IKO is the FDA product code for hammer, reflex, powered. It is a Class II device, regulated under 21 CFR 890.1450 and reviewed by the Physical Medicine panel.
What device class is IKO?
Class II, regulation 21 CFR 890.1450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IKO?
Across 1 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most IKO clearances?
Medical Dynamics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IKO
- Run a recall and safety report across every IKO manufacturer
- Watch product code IKO 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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