FDA product code HRF: Engine, Trephine, Accessories, Battery-Powered
HRF is the FDA product code for engine, trephine, accessories, battery-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel. Devices under HRF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Engine, Trephine, Accessories, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.4070 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HRF devices
openFDA lists no recalls for product code HRF.
Frequently asked questions
What is FDA product code HRF?
HRF is the FDA product code for engine, trephine, accessories, battery-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel.
What device class is HRF?
Class I, regulation 21 CFR 886.4070. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HRF
- Run a recall and safety report across every HRF manufacturer
- Watch product code HRF 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.