FDA product code KSH: Chamber, Environmental For The Storage Of Platelet Concentrate
KSH is the FDA product code for chamber, environmental for the storage of platelet concentrate. It is a Class II device, regulated under 21 CFR 864.9575 and reviewed by the Hematology panel. Devices under KSH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Environmental For The Storage Of Platelet Concentrate |
| Device class | Class II |
| Regulation | 21 CFR 864.9575 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for KSH devices
openFDA lists no recalls for product code KSH.
Frequently asked questions
What is FDA product code KSH?
KSH is the FDA product code for chamber, environmental for the storage of platelet concentrate. It is a Class II device, regulated under 21 CFR 864.9575 and reviewed by the Hematology panel.
What device class is KSH?
Class II, regulation 21 CFR 864.9575. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KSH
- Run a recall and safety report across every KSH manufacturer
- Watch product code KSH 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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