HKIClass II
Camera, Ophthalmic, Ac-Powered
21 CFR 886.1120 / Ophthalmic
HKI is the FDA product code for Camera, Ophthalmic, Ac-Powered, a class II device type, regulated under 21 CFR 886.1120. As of , FDA records hold 157 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- HKI
- Device name
- Camera, Ophthalmic, Ac-Powered
- Regulation
- 21 CFR 886.1120
- Device class
- Class II
- Review panel
- Ophthalmic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 157
- Ingested recalls
- 9
Clearances, product code HKI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1983 | 3 |
| 1984 | 2 |
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 2 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 8 |
| 1996 | 2 |
| 1997 | 5 |
| 1998 | 5 |
| 1999 | 1 |
| 2000 | 4 |
| 2001 | 2 |
| 2002 | 4 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 5 |
| 2006 | 6 |
| 2007 | 2 |
| 2008 | 5 |
| 2009 | 11 |
| 2010 | 6 |
| 2011 | 7 |
| 2012 | 5 |
| 2013 | 7 |
| 2014 | 4 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 6 |
| 2019 | 4 |
| 2020 | 5 |
| 2021 | 4 |
| 2022 | 1 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 4 |
| 2026 | 2 |
Applicants with the most clearances
Product code HKI| Applicant | Clearances |
|---|---|
| Canon Medical Components U.S.A., Inc. | 12 |
| Kowa Co., Ltd. | 9 |
| Topcon Corp. | 7 |
| Optomed | 5 |
| Canon, Inc. | 4 |
| Clarity Medical Systems | 4 |
| Nidek Technologies SRL | 4 |
| TearScience, Inc. | 4 |
| Kowa Pharmaceuticals America, Inc. | 3 |
| Medivision Medical Imaging, Ltd. | 3 |
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.