FDA product code HKN: Refractor, Manual, Non-Powered, Including Phoropter
HKN is the FDA product code for refractor, manual, non-powered, including phoropter. It is a Class I device, regulated under 21 CFR 886.1770 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HKN, from 3 different applicants. The average 510(k) review took 108 days (median 30). FDA has posted 7 recalls for HKN devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Refractor, Manual, Non-Powered, Including Phoropter |
| Device class | Class I |
| Regulation | 21 CFR 886.1770 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HKN clearance
Top HKN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Canon USA, Inc. | 1 | 1994-09-28 |
| Woodlyn, Inc. | 1 | 1987-12-23 |
| American Optical Corp. | 1 | 1979-01-26 |
Most recent HKN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K936205 | Canon USA, Inc. | COMPREHENSIVE PHOROPTER, MDR-680 | 1994-09-28 | 273 |
| K874900 | Woodlyn, Inc. | WOODLYN CLASSIC REFRACTOR, PHOROPTOR | 1987-12-23 | 22 |
| K782118 | American Optical Corp. | FUL-VUE | 1979-01-26 | 30 |
Recalls for HKN devices
7 product recalls in 6 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-02-28.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code HKN?
HKN is the FDA product code for refractor, manual, non-powered, including phoropter. It is a Class I device, regulated under 21 CFR 886.1770 and reviewed by the Ophthalmic panel.
What device class is HKN?
Class I, regulation 21 CFR 886.1770. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HKN?
Across 3 cleared submissions the average was 108 days from receipt to decision (median 30).
Which companies have the most HKN clearances?
Canon USA, Inc. (1); Woodlyn, Inc. (1); American Optical Corp. (1).
Have HKN devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2025-02-28.
Next steps
- Run an FDA pathway report with predicate devices for product code HKN
- Run a recall and safety report across every HKN manufacturer
- Watch product code HKN 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