FDA product code HRG: Engine, Trephine, Accessories, Ac-Powered
HRG is the FDA product code for engine, trephine, accessories, ac-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under HRG, from 6 different applicants. The average 510(k) review took 101 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Engine, Trephine, Accessories, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.4070 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HRG clearance
Top HRG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bkg Opthalmics USA, Inc. | 1 | 2001-12-14 |
| Laser Center Dev. Corp. | 1 | 1998-06-23 |
| Optical Systems Intl., Inc. | 1 | 1985-07-31 |
| Scanlan Intl., Inc. | 1 | 1984-06-05 |
| Edward Weck, Inc. | 1 | 1983-01-17 |
1 more applicants have HRG clearances. See the full list in Caduvo.
Most recent HRG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013151 | Bkg Opthalmics USA, Inc. | ASMOTOM AUTOMATED TREPHINE SYSTEM | 2001-12-14 | 85 |
| K981063 | Laser Center Dev. Corp. | AUTOMATED CORNEAL TREPHINE | 1998-06-23 | 92 |
| K843957 | Optical Systems Intl., Inc. | ULTRATHIN/SP LENS | 1985-07-31 | 294 |
| K841515 | Scanlan Intl., Inc. | SCANLAN VASCU-STATT II | 1984-06-05 | 54 |
| K823901 | Edward Weck, Inc. | TREPHINE BLADES-VARIOUS MODELS | 1983-01-17 | 18 |
Recalls for HRG devices
openFDA lists no recalls for product code HRG.
Frequently asked questions
What is FDA product code HRG?
HRG is the FDA product code for engine, trephine, accessories, ac-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel.
What device class is HRG?
Class I, regulation 21 CFR 886.4070. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HRG?
Across 6 cleared submissions the average was 101 days from receipt to decision (median 73).
Which companies have the most HRG clearances?
Bkg Opthalmics USA, Inc. (1); Laser Center Dev. Corp. (1); Optical Systems Intl., Inc. (1); Scanlan Intl., Inc. (1); Edward Weck, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HRG
- Run a recall and safety report across every HRG manufacturer
- Watch product code HRG 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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