Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HKI — Predicate Candidate Screening
157 FDA 510(k) clearances under this product code; the 50 most recent screened below.
103 daysmedian FDA review time
259 days90th percentile
157clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253176 | TearView | Beyond 700 Pty, Ltd. | 2026-06-22 | 269 | 0 |
| K251353 | Eyer 2 | Phelcom Technologies | 2026-01-16 | 261 | 0 |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | 2025-12-12 | 158 | 0 |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2025-09-04 | 175 | 0 |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | 2025-08-14 | 266 | 0 |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | 2025-04-30 | 55 | 0 |
| K243664 | Sentinel Camera | Ai Optics | 2024-12-17 | 20 | 0 |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | 2024-12-09 | 109 | 0 |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | 2024-05-15 | 28 | 0 |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2023-12-05 | 221 | 0 |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | 2023-11-20 | 259 | 0 |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | 2023-09-06 | 280 | 0 |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023-03-15 | 128 | 0 |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | 2023-02-22 | 292 | 0 |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | 2022-08-29 | 136 | 0 |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | 2021-04-13 | 78 | 0 |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2021-04-13 | 134 | 0 |
| K202097 | Fundus Camera | Huvitz Co., Ltd. | 2021-02-02 | 188 | 0 |
| K202221 | VX650 | Luneau Technology Operations | 2021-01-29 | 176 | 0 |
| K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | 2020-11-20 | 186 | 0 |
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | 2020-07-23 | 87 | 0 |
| K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | 2020-06-01 | 182 | 0 |
| K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | 2020-04-27 | 84 | 0 |
| K190954 | Fundus Camera | Chongqing Bio Newvision Medical Equipment , Ltd. | 2020-01-22 | 286 | 0 |
| K191945 | KOWA nonmyd 8 | Kowa Company , Ltd. | 2019-09-10 | 50 | 0 |
| K190573 | KOWA DR-1a | Kowa Company , Ltd. | 2019-06-04 | 90 | 0 |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Nidek Co., Ltd. | 2019-04-01 | 56 | 0 |
| K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019-01-02 | 141 | 0 |
| K183059 | 3nethra neo | Forus Health Pvt.Ltd | 2018-12-21 | 49 | 0 |
| K182506 | LipiScan Dynamic Meibomian Imager | Tearscience, Inc. | 2018-12-10 | 89 | 0 |
| K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | Natus Medical Incorporated | 2018-09-07 | 17 | 0 |
| K173474 | RetiCapture | Ilooda Co,., Ltd. | 2018-07-27 | 260 | 0 |
| K180306 | Nexy | Next Sight Srl | 2018-06-08 | 126 | 0 |
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora | Optomed OY | 2018-04-05 | 52 | 0 |
| K170527 | Phoenix Clinical ICON | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017-09-15 | 205 | 0 |
| K163021 | HAAG-STREIT FUNDUS MODULE 300 | Optomed OY | 2017-04-11 | 162 | 0 |
| K161727 | Eyenez Ophthalmic Camera | Eyenez, LLC | 2016-10-04 | 104 | 0 |
| K152729 | MICROPERIMETER MP-3 | Nidek Co., Ltd. | 2016-06-06 | 258 | 0 |
| K153239 | LSFG-NAVI | Softcare Co., Ltd. | 2016-05-12 | 185 | 0 |
| K152869 | LipiView II Ocular Surface Interferometer | Tearscience, Inc. | 2016-01-14 | 106 | 0 |
| K141325 | TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | 2014-10-23 | 156 | 0 |
| K141481 | TRC-NW400 NON-MYDRIATIC RETINAL CAMERA | Topcon Corporation | 2014-09-17 | 105 | 0 |
| K132987 | COBRA FUNDUS CAMERA | C.S.O. S.R.L. | 2014-07-03 | 282 | 0 |
| K140450 | KEELER KAPTURE SOFTWARE | Keeler Limited | 2014-06-17 | 113 | 0 |
| K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMA | Optomed OY | 2013-12-18 | 156 | 0 |
| K130656 | IFUSION | Optovue, Inc. | 2013-07-03 | 113 | 0 |
| K123101 | TRC-50DX RETINAL CAMERA | Topcon Medical Systems, Inc. | 2013-06-05 | 244 | 0 |
| K130289 | TRC-NW8 NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | 2013-05-10 | 94 | 0 |
| K123208 | DIGITAL RETINAL CAMERA | Canon Inc. -Medical Equipment Group | 2013-03-19 | 158 | 0 |
| K123460 | TRC-NW300 NON-MYDRIATIC RETINAL CAMERA | Topcon Medical Systems, Inc. | 2013-02-06 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda