Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carl Zeiss Meditec, Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
269 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243878 | CLARUS (700) | Carl Zeiss Meditec, Inc. | 2025-04-17 | 120 | 0 |
| K233933 | CIRRUS™ HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | 2024-05-17 | 155 | 0 |
| K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | 2023-09-22 | 225 | 0 |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with F | Carl Zeiss Meditec, Inc. | 2023-06-20 | 67 | 0 |
| K222200 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2023-04-13 | 262 | 0 |
| K191194 | CLARUS | Carl Zeiss Meditec, Inc. | 2019-06-25 | 53 | 0 |
| K181534 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2019-02-15 | 249 | 0 |
| K181444 | CLARUS | Carl Zeiss Meditec, Inc. | 2019-01-10 | 223 | 0 |
| K182318 | Retina Workplace | Carl Zeiss Meditec, Inc. | 2018-10-24 | 58 | 0 |
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | 2018-04-13 | 168 | 0 |
| K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | 2016-10-26 | 182 | 0 |
| K150977 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2015-09-01 | 141 | 0 |
| K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015-07-10 | 238 | 0 |
| K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR | Carl Zeiss Meditec, Inc. | 2013-06-26 | 114 | 0 |
| K121653 | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS | Carl Zeiss Meditec, Inc. | 2012-12-27 | 205 | 1 |
| K112184 | CIRRUS PHOTO | Carl Zeiss Meditec, Inc. | 2012-06-18 | 326 | 0 |
| K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC | Carl Zeiss Meditec, Inc. | 2012-01-19 | 269 | 0 |
| K093213 | GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER I | Carl Zeiss Meditec, Inc. | 2010-03-12 | 150 | 0 |
| K093521 | GDXPRO | Carl Zeiss Meditec, Inc. | 2009-11-25 | 12 | 0 |
| K082016 | GDX VCC WITH ECC SOFTWARE | Carl Zeiss Meditec, Inc. | 2009-08-10 | 391 | 0 |
| K083291 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NOR | Carl Zeiss Meditec, Inc. | 2009-05-05 | 179 | 2 |
| K090439 | FORUM | Carl Zeiss Meditec, Inc. | 2009-03-25 | 33 | 0 |
| K063378 | CIRRUS HD-OCT, MODEL 4000 | Carl Zeiss Meditec, Inc. | 2007-01-26 | 79 | 0 |
| K051789 | VISANTE OCT | Carl Zeiss Meditec, Inc. | 2005-09-30 | 91 | 0 |
| K033123 | STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE | Carl Zeiss Meditec, Inc. | 2004-04-20 | 203 | 1 |
| K030433 | STRATUSOCT WITH RNFL NORMATIVE DATABASE | Carl Zeiss Meditec, Inc. | 2003-05-01 | 80 | 1 |
| K951132 | ANGIOSCAN (AS STAND ALONE INSTRUMENT) | Carl Zeiss Meditec, Inc. | 1995-06-26 | 105 | 0 |
| K941705 | NERVE FIBER ANALYZER | Carl Zeiss Meditec, Inc. | 1994-07-18 | 103 | 0 |
| K923742 | TOPOGRAPHIC SCANNING SYSTEM TOPSS | Carl Zeiss Meditec, Inc. | 1993-03-26 | 242 | 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