FDA product code HKK: Telescope, Spectacle, Low-Vision
HKK is the FDA product code for telescope, spectacle, low-vision. It is a Class I device, regulated under 21 CFR 886.5870 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HKK, from 2 different applicants. The average 510(k) review took 42 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Telescope, Spectacle, Low-Vision |
| Device class | Class I |
| Regulation | 21 CFR 886.5870 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HKK clearance
Top HKK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keeler Instruments, Inc. | 1 | 1987-02-12 |
| Global Eye Care, Inc. | 1 | 1987-01-20 |
Most recent HKK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870203 | Keeler Instruments, Inc. | KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 | 1987-02-12 | 23 |
| K864594 | Global Eye Care, Inc. | DUALENZ LOW VISION EYEWEAR | 1987-01-20 | 60 |
Recalls for HKK devices
openFDA lists no recalls for product code HKK.
Frequently asked questions
What is FDA product code HKK?
HKK is the FDA product code for telescope, spectacle, low-vision. It is a Class I device, regulated under 21 CFR 886.5870 and reviewed by the Ophthalmic panel.
What device class is HKK?
Class I, regulation 21 CFR 886.5870. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HKK?
Across 2 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most HKK clearances?
Keeler Instruments, Inc. (1); Global Eye Care, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HKK
- Run a recall and safety report across every HKK manufacturer
- Watch product code HKK 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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