FDA product code HKC: Spectacle Microscope, Low-Vision
HKC is the FDA product code for spectacle microscope, low-vision. It is a Class I device, regulated under 21 CFR 886.5540 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HKC. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Spectacle Microscope, Low-Vision |
| Device class | Class I |
| Regulation | 21 CFR 886.5540 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HKC clearance
Top HKC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Almore Intl., Inc. | 1 | 1983-04-06 |
Most recent HKC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830774 | Almore Intl., Inc. | BINOCULAR MAGNIFIER 2X | 1983-04-06 | 26 |
Recalls for HKC devices
openFDA lists no recalls for product code HKC.
Frequently asked questions
What is FDA product code HKC?
HKC is the FDA product code for spectacle microscope, low-vision. It is a Class I device, regulated under 21 CFR 886.5540 and reviewed by the Ophthalmic panel.
What device class is HKC?
Class I, regulation 21 CFR 886.5540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HKC?
Across 1 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most HKC clearances?
Almore Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HKC
- Run a recall and safety report across every HKC manufacturer
- Watch product code HKC 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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