FDA product code HRK: Table, Instrument, Manual, Ophthalmic
HRK is the FDA product code for table, instrument, manual, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4855 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HRK, from 2 different applicants. The average 510(k) review took 90 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Table, Instrument, Manual, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4855 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HRK clearance
Top HRK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Edwards Laboratories | 1 | 1984-11-05 |
| Alcon Laboratories | 1 | 1976-11-02 |
Most recent HRK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842410 | American Edwards Laboratories | AMER. EDWARDS LAB FLEXISCOPE | 1984-11-05 | 139 |
| K760697 | Alcon Laboratories | EVANS ARM AND HAND REST | 1976-11-02 | 41 |
Recalls for HRK devices
openFDA lists no recalls for product code HRK.
Frequently asked questions
What is FDA product code HRK?
HRK is the FDA product code for table, instrument, manual, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4855 and reviewed by the Ophthalmic panel.
What device class is HRK?
Class I, regulation 21 CFR 886.4855. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HRK?
Across 2 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most HRK clearances?
American Edwards Laboratories (1); Alcon Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HRK
- Run a recall and safety report across every HRK manufacturer
- Watch product code HRK 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times