FDA product code KYS: Insoles, Medical
KYS is the FDA product code for insoles, medical. It is a Class I device, regulated under 21 CFR 880.6280 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under KYS. The average 510(k) review took 162 days (median 162).
Classification
| Field | Value |
|---|---|
| Device name | Insoles, Medical |
| Device class | Class I |
| Regulation | 21 CFR 880.6280 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KYS clearance
Top KYS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Combe, Inc. | 1 | 1978-10-10 |
Most recent KYS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780719 | Combe, Inc. | FUNGUS FIGHTER INSOLES | 1978-10-10 | 162 |
Recalls for KYS devices
openFDA lists no recalls for product code KYS.
Frequently asked questions
What is FDA product code KYS?
KYS is the FDA product code for insoles, medical. It is a Class I device, regulated under 21 CFR 880.6280 and reviewed by the General Hospital panel.
What device class is KYS?
Class I, regulation 21 CFR 880.6280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYS?
Across 1 cleared submissions the average was 162 days from receipt to decision (median 162).
Which companies have the most KYS clearances?
Combe, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KYS
- Run a recall and safety report across every KYS manufacturer
- Watch product code KYS 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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