Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HLI — Predicate Candidate Screening
87 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
219 days90th percentile
87clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016-02-11 | 111 | 0 |
| K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2015-12-02 | 257 | 0 |
| K142953 | OCT-Camera | Optomedical Technologies GmbH | 2015-03-04 | 145 | 0 |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Propper Manufacturing Co., Inc. | 2014-09-17 | 90 | 0 |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Centervue S.P.A. | 2014-04-23 | 133 | 0 |
| K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES | Amico Diagnostic Incorporated | 2014-03-26 | 272 | 0 |
| K133892 | IVUE 500 | Optovue, Inc. | 2014-03-19 | 89 | 0 |
| K123316 | HEINE OMEGA 500 | Heine Optotechnik GmbH & Co. KG | 2013-02-26 | 124 | 0 |
| K121739 | IVUE WITH NORMATIVE DATABASE | Optovue, Inc. | 2013-01-18 | 219 | 1 |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | Bioptigen, Inc. | 2012-05-11 | 123 | 0 |
| K120238 | RTVUE XR OCT | Optovue, Inc. | 2012-04-03 | 68 | 0 |
| K111531 | RHA2020 | Annidis Health Systems Corp. | 2011-07-08 | 36 | 0 |
| K103266 | ISTAND | Optovue, Inc. | 2011-06-03 | 211 | 0 |
| K110205 | AAIO-7, AAIO WIRLESS | Appasamy Associates | 2011-02-09 | 15 | 0 |
| K101505 | RTVUE MODEL RTVUE 100 | Optovue, Inc. | 2010-09-15 | 106 | 1 |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Optovue, Inc. | 2010-06-17 | 83 | 0 |
| K063378 | CIRRUS HD-OCT, MODEL 4000 | Carl Zeiss Meditec, Inc. | 2007-01-26 | 79 | 0 |
| K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | Bioptigen, Inc. | 2006-12-13 | 37 | 0 |
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2006-08-23 | 70 | 0 |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 2006-05-23 | 57 | 0 |
| K051789 | VISANTE OCT | Carl Zeiss Meditec, Inc. | 2005-09-30 | 91 | 0 |
| K042885 | OCT-OPTHALMOSCOPE | Ophthalmic Technologies, Inc. | 2005-01-21 | 94 | 0 |
| K042001 | PANORAMIC 200A | Optos Plc. | 2004-10-07 | 73 | 0 |
| K041290 | RTA MODEL D RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2004-05-24 | 11 | 0 |
| K033123 | STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE | Carl Zeiss Meditec, Inc. | 2004-04-20 | 203 | 1 |
| K031312 | RTA MODEL D RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2003-05-06 | 12 | 0 |
| K030433 | STRATUSOCT WITH RNFL NORMATIVE DATABASE | Carl Zeiss Meditec, Inc. | 2003-05-01 | 80 | 1 |
| K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE | Welch Allyn, Inc. | 2001-01-25 | 87 | 0 |
| K994340 | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ | Hai Laboratories, Inc. | 2000-09-20 | 272 | 0 |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | Canon USA, Inc. | 2000-06-21 | 323 | 0 |
| K000731 | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2000-03-31 | 25 | 0 |
| K983999 | PANORAMIC200 OPTHALMOSCOPE | Optos Plc. | 1999-02-03 | 86 | 0 |
| K981640 | S2LO | Odyssey Optical Systems, LLC | 1998-08-05 | 89 | 0 |
| K971671 | HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) | Heidelberg Engineering | 1997-07-29 | 83 | 0 |
| K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE | Mira, Inc. | 1997-03-19 | 706 | 0 |
| K964137 | RTA RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 1997-02-03 | 111 | 0 |
| K961171 | HUMPHREY OCT SCANNER | Carl Zeiss, Inc. | 1996-06-21 | 88 | 0 |
| K951132 | ANGIOSCAN (AS STAND ALONE INSTRUMENT) | Carl Zeiss Meditec, Inc. | 1995-06-26 | 105 | 0 |
| K951210 | WELCH ALLYN VIDEO OPHTHALMOSCOPE | Welch Allyn, Inc. | 1995-06-06 | 81 | 0 |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | Neitz Instruments Company, Ltd. | 1995-04-07 | 14 | 0 |
| K950461 | WELCH ALLYN OPHTHALMOSCOPE | Welch Allyn, Inc. | 1995-04-04 | 60 | 0 |
| K944261 | RETINA ANGIOGRAPH | Heidelberg Engineering | 1994-11-14 | 74 | 0 |
| K943955 | RETINA FLOWMETER | Heidelberg Engineering | 1994-11-14 | 91 | 0 |
| K943956 | RETINA TOMOGRAPH AND FLOWMETER | Heidelberg Engineering | 1994-11-14 | 91 | 0 |
| K942715 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942713 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942712 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942714 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942711 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-123 | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 0 |
| K942720 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 | Neitz Instruments Company, Ltd. | 1994-08-05 | 57 | 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