Canon Inc.
Catalogue number RK-F2, listed by Canon Inc., Japan, under Refractometer, Ophthalmic. 17 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (4), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Chongqing Yeasn Science-Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Refractometer, Ophthalmic
Record
| Listed by | Canon Inc., Japan |
|---|---|
| FDA product code | HKO |
| Device type | Refractometer, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1760 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2026-03-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RK-F2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Righton | Right MFG. Co., Ltd. | 27 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 13 |
| Visionix | Right MFG. Co., Ltd. | 13 |
| Auto REF/Keratometer | Ningbo Ming Sing Optical R&D Co., Ltd. | 6 |
| Microclear | Suzhou Microclear Medical Instruments Co., Ltd. | 6 |
| Rexxam | Rexxam.co., Ltd. | 5 |
| Auto Refractometer | Nidek Incorporated | 4 |
| plusoptiX 12 | Plusoptix Gmbh | 4 |
| Auto Refkeratometer | Tomey Corporation | 4 |
| MediWorks | Shanghai Mediworks Precision Instruments Co., Ltd. | 3 |
| Auto Refractometer RM-800 | Topcon Corp. | 3 |
| Yeasn | Chongqing Yeasn Science-Technology Co., Ltd. | 3 |
Showing 12 of 52. All products under Refractometer, Ophthalmic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K940516 | 1994-07-12 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-12-05 | Class II | Software design | Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probabilit | 384 units | 2013-09-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.