FDA product code NKR: System, Catheter Control, Reprocessed
NKR is the FDA product code for system, catheter control, reprocessed. It is a Class II device, regulated under 21 CFR 870.1290 and reviewed by the Cardiovascular panel. Devices under NKR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | System, Catheter Control, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1290 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NKR devices
openFDA lists no recalls for product code NKR.
Frequently asked questions
What is FDA product code NKR?
NKR is the FDA product code for system, catheter control, reprocessed. It is a Class II device, regulated under 21 CFR 870.1290 and reviewed by the Cardiovascular panel.
What device class is NKR?
Class II, regulation 21 CFR 870.1290. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NKR
- Run a recall and safety report across every NKR manufacturer
- Watch product code NKR 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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