FDA product code KKM: Methylene Blue Thiocyanate
KKM is the FDA product code for methylene blue thiocyanate. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under KKM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Methylene Blue Thiocyanate |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KKM devices
openFDA lists no recalls for product code KKM.
Frequently asked questions
What is FDA product code KKM?
KKM is the FDA product code for methylene blue thiocyanate. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KKM?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KKM
- Run a recall and safety report across every KKM manufacturer
- Watch product code KKM 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.