FDA product code NKY: Blade, Keratome, Reprocessed
NKY is the FDA product code for blade, keratome, reprocessed. It is a Class I device, regulated under 21 CFR 886.4370 and reviewed by the Ophthalmic panel. Devices under NKY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Blade for keratome to make flap in cornea for LASIK refractive surgery. Same as previously cleared blade for keratomes, product codes HMY and HNO, except this is reprocessed. 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 | Blade, Keratome, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 886.4370 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NKY devices
openFDA lists no recalls for product code NKY.
Frequently asked questions
What is FDA product code NKY?
NKY is the FDA product code for blade, keratome, reprocessed. It is a Class I device, regulated under 21 CFR 886.4370 and reviewed by the Ophthalmic panel.
What device class is NKY?
Class I, regulation 21 CFR 886.4370. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NKY
- Run a recall and safety report across every NKY manufacturer
- Watch product code NKY 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.