HKXClass II
Tonometer, Ac-Powered
21 CFR 886.1930 / Ophthalmic
HKX is the FDA product code for Tonometer, Ac-Powered, a class II device type, regulated under 21 CFR 886.1930. As of , FDA records hold 58 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HKX
- Device name
- Tonometer, Ac-Powered
- Regulation
- 21 CFR 886.1930
- 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
- No
- Ingested clearances
- 58
- Ingested recalls
- 0
Clearances, product code HKX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1982 | 1 |
| 1984 | 4 |
| 1986 | 3 |
| 1987 | 7 |
| 1989 | 2 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 3 |
| 1997 | 1 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 2 |
| 2006 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2023 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code HKX| Applicant | Clearances |
|---|---|
| Bio-Rad | 5 |
| Keeler Instruments, Inc. | 5 |
| CooperVision, Inc. | 2 |
| Luneau SAS | 2 |
| Ocular Blood Flow Laboratories, Inc. | 2 |
| Reichert, Inc. | 2 |
| Accutome Ultrasound, Inc. | 1 |
| American Optical Corp. | 1 |
| Ameritek, Inc. | 1 |
| Canon Inc. -Medical Equipment Group | 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.