FDA product code HJY: Reader, Bar, Ophthalmic
HJY is the FDA product code for reader, bar, ophthalmic. It is a Class I device, regulated under 21 CFR 886.5800 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HJY. The average 510(k) review took 62 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Reader, Bar, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.5800 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HJY clearance
Top HJY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sherwood Medical Industries | 1 | 1978-10-24 |
Most recent HJY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781459 | Sherwood Medical Industries | MONOJECT SCALE MAGNIFIER | 1978-10-24 | 62 |
Recalls for HJY devices
openFDA lists no recalls for product code HJY.
Frequently asked questions
What is FDA product code HJY?
HJY is the FDA product code for reader, bar, ophthalmic. It is a Class I device, regulated under 21 CFR 886.5800 and reviewed by the Ophthalmic panel.
What device class is HJY?
Class I, regulation 21 CFR 886.5800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJY?
Across 1 cleared submissions the average was 62 days from receipt to decision (median 62).
Which companies have the most HJY clearances?
Sherwood Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJY
- Run a recall and safety report across every HJY manufacturer
- Watch product code HJY 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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