FDA product code PKG: Bone Marrow Processing Device To Support Hematopoietic Reconstitution
PKG is the FDA product code for bone marrow processing device to support hematopoietic reconstitution. It is a Class II device, regulated under 21 CFR 864.9245 and reviewed by the Hematology panel. Devices under PKG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient.
Classification
| Field | Value |
|---|---|
| Device name | Bone Marrow Processing Device To Support Hematopoietic Reconstitution |
| Device class | Class II |
| Regulation | 21 CFR 864.9245 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for PKG devices
openFDA lists no recalls for product code PKG.
Frequently asked questions
What is FDA product code PKG?
PKG is the FDA product code for bone marrow processing device to support hematopoietic reconstitution. It is a Class II device, regulated under 21 CFR 864.9245 and reviewed by the Hematology panel.
What device class is PKG?
Class II, regulation 21 CFR 864.9245. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PKG
- Run a recall and safety report across every PKG manufacturer
- Watch product code PKG 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.