HKOClass I
Refractometer, Ophthalmic
21 CFR 886.1760 / Ophthalmic
HKO is the FDA product code for Refractometer, Ophthalmic, a class I device type, regulated under 21 CFR 886.1760. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- HKO
- Device name
- Refractometer, Ophthalmic
- Regulation
- 21 CFR 886.1760
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 35
- Ingested recalls
- 5
Clearances, product code HKO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1980 | 2 |
| 1981 | 4 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1986 | 4 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 1 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 2 |
| 2000 | 1 |
| 2003 | 1 |
Applicants with the most clearances
Product code HKO| Applicant | Clearances |
|---|---|
| Nidek, Inc. | 7 |
| Canon Medical Components U.S.A., Inc. | 4 |
| American Optical Corp. | 3 |
| Stereo Optical Company LLC | 3 |
| Bausch & Lomb Incorporated | 2 |
| R.H. Burton Co. | 2 |
| Allergan Humphrey | 1 |
| Cannon U.S.A., Inc. | 1 |
| Canon, Inc. | 1 |
| Cavitron Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.