Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HJO — Predicate Candidate Screening
108 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
265 days90th percentile
108clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | 2026-03-18 | 107 | 0 |
| K231760 | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | 2024-03-08 | 266 | 0 |
| K222372 | Kowa SL-19 | Kowa Company , Ltd. | 2022-11-21 | 108 | 0 |
| K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020-01-14 | 57 | 0 |
| K182306 | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2018-11-22 | 90 | 0 |
| K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018-08-24 | 256 | 0 |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. | 2017-12-21 | 181 | 0 |
| K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017-10-06 | 232 | 0 |
| K162778 | Portable Slit Lamp Microscope | Suzhou Kangjie Medical, Inc. | 2017-07-21 | 294 | 0 |
| K162684 | SL 220 | Carl Zeiss Meditec, AG | 2017-05-31 | 247 | 0 |
| K163564 | SLIT LAMP SL-2000 | Nidek Co., Ltd. | 2017-05-19 | 151 | 0 |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | 2017-04-14 | 205 | 0 |
| K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017-04-06 | 77 | 0 |
| K161607 | VISULUX | Carl Zeiss Meditec, AG | 2017-02-23 | 258 | 0 |
| K161764 | SLIT LAMP, Model: YF-100 | Chongqing Yeasn Science-Technology Co., Ltd. | 2017-02-16 | 234 | 0 |
| K161972 | Slit Lamp SL-D301 | Topcon Corporation | 2016-12-09 | 144 | 0 |
| K160327 | ALADDIN HW3.0 | Visia Imaging S.R.L. | 2016-10-05 | 243 | 0 |
| K153545 | Portable Slit Lamp | Shanghai Bolan Optical-Electric Co., Ltd. | 2016-06-22 | 194 | 0 |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | 2016-05-26 | 265 | 0 |
| K152429 | Slit Lamp Microscope | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2016-05-11 | 259 | 0 |
| K151394 | Keeler Slit Lamp | Keeler Limited | 2015-09-10 | 107 | 0 |
| K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015-07-10 | 238 | 0 |
| K141954 | XCEL 455 SLIT LAMP | Reichert, Inc. | 2014-10-15 | 89 | 0 |
| K141068 | ZEISS CATARACT SUITE MARKERLESS | Carl Zeiss Meditec, AG | 2014-09-09 | 138 | 0 |
| K133667 | SLIT LAMP SL-D701 | Topcon Corp. | 2014-08-26 | 270 | 0 |
| K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEE | Keeler Limited | 2014-07-11 | 137 | 0 |
| K133062 | DISCOVERY SYSTEM | Innovative Visual Systems | 2014-06-20 | 266 | 0 |
| K133132 | OPTICAL BIOMETER AL-SCAN | Nidek Co., Ltd. | 2014-06-11 | 254 | 0 |
| K131567 | ALADDIN | Visia Imaging S.R.L. | 2014-06-05 | 371 | 0 |
| K131711 | YZ3 PORTABLE SLIT LAMP | Suzhou 66 Vision Tech Co., Ltd. | 2014-05-09 | 332 | 0 |
| K133755 | KOWA SL-17 | Kowa Co. , Ltd. | 2014-03-11 | 92 | 0 |
| K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION | Carl Zeiss Meditec, AG | 2014-02-12 | 92 | 0 |
| K131589 | KEELER SLIT LAMP H-SERIES | Keeler, Ltd. | 2013-06-27 | 27 | 0 |
| K122418 | IOLMASTER 500 | Carl Zeiss Meditec, AG | 2013-04-12 | 247 | 4 |
| K110129 | RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION | Rightmedical Products, LLC | 2011-08-30 | 224 | 0 |
| K110489 | SLIT LAMP SL-2G | Topcon Medical Systems, Inc. | 2011-05-23 | 90 | 0 |
| K101182 | IOLMASTER 500 | Carl Zeiss Meditec, AG | 2010-11-03 | 190 | 4 |
| K100439 | MEDIWORKS SLIT LAMP | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2010-07-16 | 149 | 0 |
| K100202 | SLIT LAMP BO 900, BQ 900, BP900 | Haag-Streit AG | 2010-03-19 | 53 | 0 |
| K100500 | PSL CLASSIC SLIT LAMP | Keeler Instruments, Inc. | 2010-03-09 | 15 | 0 |
| K093021 | ATLANTIS SLIT LAMP | Us Opthalmic, LLC | 2010-01-28 | 121 | 0 |
| K092883 | LED LAMP OR OTHER | Intravista Medical Systems, Inc. | 2009-12-18 | 91 | 0 |
| K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 | Huvitz Co., Ltd. | 2009-12-03 | 9 | 0 |
| K082891 | LENSTAR, MODEL LS900 | Haag-Streit AG | 2009-10-20 | 385 | 2 |
| K080776 | GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL7 | Us Ophthalmic, LLC | 2008-09-09 | 174 | 0 |
| K082031 | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES | Appasamy Associates | 2008-07-31 | 14 | 0 |
| K072861 | CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATI | Acheve Technology, Inc. | 2008-06-24 | 263 | 0 |
| K073190 | SLIT LAMP | Huvitz Co., Ltd. | 2008-01-11 | 59 | 0 |
| K063352 | ELLEX SLIT LAMP, MODEL 30XL | Takagi Seiko Co., Ltd. | 2007-03-13 | 127 | 0 |
| K063750 | XCEL 255 SLIT LAMP | Reichert, Inc. | 2006-12-20 | 1 | 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