FDA product code KSM: System, Test, Combs, Automated
KSM is the FDA product code for system, test, combs, automated. It is a Class II device, regulated under 21 CFR 864.9300 and reviewed by the Hematology panel. Devices under KSM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Combs, Automated |
| Device class | Class II |
| Regulation | 21 CFR 864.9300 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for KSM devices
openFDA lists no recalls for product code KSM.
Frequently asked questions
What is FDA product code KSM?
KSM is the FDA product code for system, test, combs, automated. It is a Class II device, regulated under 21 CFR 864.9300 and reviewed by the Hematology panel.
What device class is KSM?
Class II, regulation 21 CFR 864.9300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code KSM
- Run a recall and safety report across every KSM manufacturer
- Watch product code KSM 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.