HKI · Class II · 21 CFR 886.1120

FDA Product Code HKI: Camera, Ophthalmic, Ac-powered

Leading manufacturers include Canon, Inc., Phelcom Technologies and Crystalvue Medical Corporation.

156
Total
156
Cleared
122d
Avg days
1977
Since
Stable submission activity - 7 submissions in the last 2 years
Review times increasing: avg 149d recently vs 120d historically

FDA 510(k) Cleared Camera, Ophthalmic, Ac-powered Devices (Product Code HKI)

156 devices
1–24 of 156
Cleared Jan 16, 2026
Eyer 2
K251353
Phelcom Technologies
Ophthalmic · 261d
Cleared Dec 12, 2025
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120
Remidio Innovative Solutions Private Limited
Ophthalmic · 158d
Cleared Sep 04, 2025
Optina-4C (MHRC-C1N)
K250770
Optina Diagnostics, Inc.
Ophthalmic · 175d
Cleared Aug 14, 2025
3nethra neo HD FA
K243600
Forus Health Pvt.Ltd
Ophthalmic · 266d
Cleared Apr 30, 2025
Resolve Fundus Camera
K250683
Optain Health, Inc.
Ophthalmic · 55d
Cleared Dec 17, 2024
Sentinel Camera
K243664
Ai Optics
Ophthalmic · 20d
Cleared Dec 09, 2024
Verily Numetric Retinal Camera
K242508
Verily Life Sciences, LLC
Ophthalmic · 109d
Cleared May 15, 2024
CANON Fundus Camera CR-10 (CR-10)
K241049
Canon, Inc.
Ophthalmic · 28d
Cleared Dec 05, 2023
Optina-4C (MHRC-C1N)
K231230
Optina Diagnostics, Inc.
Ophthalmic · 221d
Cleared Nov 20, 2023
Zilia Ocular FC (ZIL-10002)
K230627
Zilia, Inc.
Ophthalmic · 259d
Cleared Sep 06, 2023
Phoenix ICON, Phoenix ICON GO
K223575
Neolight, LLC
Ophthalmic · 280d
Cleared Mar 15, 2023
iExaminer System with Panoptic Plus
K223381
Welch Allyn, Inc.
Ophthalmic · 128d
Cleared Feb 22, 2023
Eyer Retinal Camera NM-STD
K221329
Phelcom Technologies
Ophthalmic · 292d
Cleared Aug 29, 2022
Non-Mydriatic Retinal Camera NW500
K221111
Topcon Corporation
Ophthalmic · 136d
Cleared Apr 13, 2021
RetCam Envision
K203500
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Ophthalmic · 134d
Cleared Apr 13, 2021
NFC-600 Automated Portable Retinal Camera
K210197
Crystalvue Medical Corporation
Ophthalmic · 78d
Cleared Feb 02, 2021
Fundus Camera
K202097
Huvitz Co., Ltd.
Ophthalmic · 188d
Cleared Jan 29, 2021
VX650
K202221
Luneau Technology Operations
Ophthalmic · 176d
Cleared Nov 20, 2020
Optomed Smartscope M5 with Optomed Smartscope FA
K201325
Optomed Oyj
Ophthalmic · 186d
Cleared Jul 23, 2020
Canon non-mydriatic retinal camera CR series
K201122
Canon, Inc.
Ophthalmic · 87d
Cleared Jun 01, 2020
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
K193319
Vasoptic Medical, Inc.
Ophthalmic · 182d
Cleared Apr 27, 2020
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
K200254
Optina Diagnostics
Ophthalmic · 84d
Cleared Jan 22, 2020
Fundus Camera
K190954
Chongqing Bio Newvision Medical Equipment , Ltd.
Ophthalmic · 286d
Cleared Sep 10, 2019
KOWA nonmyd 8
K191945
Kowa Company , Ltd.
Ophthalmic · 50d

About Product Code HKI - Regulatory Context

510(k) Submission Activity

156 total 510(k) submissions under product code HKI since 1977, with 156 receiving FDA clearance (average review time: 122 days).

Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.

FDA 510(k) Review Time - HKI Product Code

Recent submissions under HKI have taken an average of 149 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.

HKI devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →