Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OBO — Predicate Candidate Screening
66 FDA 510(k) clearances under this product code; the 50 most recent screened below.
156 daysmedian FDA review time
326 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2026-05-07 | 157 | 0 |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 2025-12-23 | 125 | 0 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | 2025-07-18 | 143 | 0 |
| K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2025-05-12 | 49 | 0 |
| K240924 | Anterion | Heidelberg Engineering GmbH | 2024-12-13 | 253 | 0 |
| K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2024-10-11 | 168 | 0 |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); I | Topcon Corporation | 2024-07-17 | 89 | 0 |
| K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2024-07-01 | 157 | 0 |
| K233933 | CIRRUS™ HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | 2024-05-17 | 155 | 0 |
| K233602 | P200TE (A10700) | Optos Plc. | 2024-05-09 | 182 | 0 |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024-04-10 | 156 | 0 |
| K233421 | RESCAN 700 | Carl Zeiss Meditec, AG | 2024-03-08 | 150 | 0 |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023-10-30 | 185 | 0 |
| K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2023-10-20 | 329 | 0 |
| K230897 | Anterion | Heidelberg Engineering GmbH | 2023-10-11 | 194 | 0 |
| K221601 | MS-39 | C.S.O. S.R.L. | 2023-09-01 | 456 | 0 |
| K231673 | P200TE (A10700) | Optos Plc. | 2023-08-18 | 71 | 0 |
| K222200 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2023-04-13 | 262 | 0 |
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with I | Nidek Co., Ltd. | 2023-03-30 | 328 | 0 |
| K222166 | SOLIX | Optovue, Inc. | 2022-11-09 | 111 | 0 |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | 2022-04-27 | 209 | 0 |
| K211817 | Anterion | Heidelberg Engineering GmbH | 2021-11-05 | 147 | 0 |
| K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | 2020-09-09 | 121 | 0 |
| K200516 | OCT-Camera ID 21101A3 | Optomedical Technologies GmbH | 2020-09-02 | 184 | 0 |
| K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | 2019-09-26 | 23 | 0 |
| K190732 | P200TxE | Optos Plc. | 2019-07-31 | 132 | 0 |
| K182942 | Canon OCT-A1 | Canon, Inc. | 2019-07-24 | 274 | 0 |
| K181534 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2019-02-15 | 249 | 0 |
| K180229 | RESCAN 700, CALLISTO eye | Carl Zeiss Meditec, AG | 2019-01-11 | 350 | 0 |
| K182569 | Spectralis HRA+OCT and variants with High Magnification Modu | Heidelberg Engineering GmbH | 2018-10-18 | 30 | 0 |
| K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH | 2018-09-13 | 87 | 0 |
| K173648 | Spectralis HRA + OCT and variants | Heidelberg Engineering GmbH | 2018-08-30 | 276 | 0 |
| K180660 | Avanti | Optovue, Inc. | 2018-06-08 | 86 | 0 |
| K173707 | P200TE | Optos Plc. | 2018-02-28 | 86 | 0 |
| K173119 | DRI OCT Triton | Topcon Corporation | 2018-01-19 | 112 | 0 |
| K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectr | Heidelberg Engineering GmbH | 2017-11-01 | 57 | 0 |
| K163195 | PRIMUS | Carl Zeiss Suzhou Co., Ltd. | 2017-06-21 | 218 | 0 |
| K163475 | iVue | Optovue, Inc. | 2017-06-09 | 179 | 0 |
| K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017-03-03 | 44 | 0 |
| K162783 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2016-12-09 | 67 | 0 |
| K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | 2016-10-26 | 182 | 0 |
| K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016-07-28 | 57 | 0 |
| K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis | Heidelberg Engineering GmbH | 2016-05-06 | 274 | 0 |
| K150977 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2015-09-01 | 141 | 0 |
| K141844 | RESCAN 700, CALLISTO EYE | Carl Zeiss Meditec, AG | 2014-11-18 | 133 | 0 |
| K133217 | CIRRUS PHOTO | Carl Zeiss Meditec, AG | 2014-03-19 | 152 | 0 |
| K132323 | RS-3000 ADVANCE | Nidek Co., Ltd. | 2014-02-19 | 209 | 0 |
| K121622 | NIDEK RS-3000 | Nidek Co., Ltd. | 2013-03-14 | 286 | 0 |
| K121043 | OPTOS OCT/SLO MICROPERIMETER | Optos Plc. | 2013-02-22 | 323 | 0 |
| K121993 | SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECT | Heidelberg Engineering GmbH | 2012-10-25 | 111 | 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