FDA product code HKW: Prism, Bar, Ophthalmic
HKW is the FDA product code for prism, bar, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1650 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HKW, from 2 different applicants. The average 510(k) review took 78 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Prism, Bar, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1650 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HKW clearance
Top HKW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National Reading Service | 1 | 1991-07-26 |
| Roseburg SA | 1 | 1985-05-23 |
Most recent HKW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911374 | National Reading Service | PLASTIC OVERLAYS | 1991-07-26 | 120 |
| K851555 | Roseburg SA | OPTHALMIC BAR PRISM | 1985-05-23 | 37 |
Recalls for HKW devices
openFDA lists no recalls for product code HKW.
Frequently asked questions
What is FDA product code HKW?
HKW is the FDA product code for prism, bar, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1650 and reviewed by the Ophthalmic panel.
What device class is HKW?
Class I, regulation 21 CFR 886.1650. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HKW?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most HKW clearances?
National Reading Service (1); Roseburg SA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HKW
- Run a recall and safety report across every HKW manufacturer
- Watch product code HKW 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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