Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carl Zeiss Meditec, AG · Predicate Candidate Screening
46 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
270 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260694 | ZEISS CLINIC 360 | Carl Zeiss Meditec, AG | 2026-07-17 | 136 | 0 |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INT | Carl Zeiss Meditec, AG | 2025-01-10 | 259 | 0 |
| K233911 | VISULAS combi | Carl Zeiss Meditec, AG | 2024-09-06 | 269 | 0 |
| K240215 | BLUE 400; BLUE 400 S | Carl Zeiss Meditec, AG | 2024-06-28 | 154 | 0 |
| K233421 | RESCAN 700 | Carl Zeiss Meditec, AG | 2024-03-08 | 150 | 0 |
| K232944 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-12-21 | 92 | 0 |
| K232159 | QEVO System | Carl Zeiss Meditec, AG | 2023-09-21 | 63 | 0 |
| K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-08-28 | 80 | 0 |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | 2023-07-31 | 124 | 0 |
| K213527 | FORUM | Carl Zeiss Meditec, AG | 2022-08-15 | 284 | 0 |
| K211346 | BLUE 400 | Carl Zeiss Meditec, AG | 2022-07-22 | 445 | 0 |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | 2022-04-19 | 274 | 0 |
| K211156 | CONVIVO In Vivo Pathology Suite | Carl Zeiss Meditec, AG | 2021-12-29 | 254 | 0 |
| K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | 2020-06-15 | 193 | 0 |
| K181682 | VISULAS green | Carl Zeiss Meditec, AG | 2019-03-06 | 253 | 0 |
| K180229 | RESCAN 700, CALLISTO eye | Carl Zeiss Meditec, AG | 2019-01-11 | 350 | 0 |
| K181116 | CONVIVO | Carl Zeiss Meditec, AG | 2018-10-25 | 181 | 0 |
| K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018-08-24 | 256 | 0 |
| K180858 | CALLISTO eye | Carl Zeiss Meditec, AG | 2018-06-27 | 86 | 0 |
| K180839 | AT 030 | Carl Zeiss Meditec, AG | 2018-06-07 | 69 | 0 |
| K170667 | QEVO System with KINEVO 900 | Carl Zeiss Meditec, AG | 2017-08-18 | 165 | 0 |
| K162991 | YELLOW 560 Fluorescence Module | Carl Zeiss Meditec, AG | 2017-07-24 | 270 | 0 |
| K170638 | Retina Workplace | Carl Zeiss Meditec, AG | 2017-06-21 | 111 | 0 |
| K162684 | SL 220 | Carl Zeiss Meditec, AG | 2017-05-31 | 247 | 0 |
| K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017-04-06 | 77 | 0 |
| K161607 | VISULUX | Carl Zeiss Meditec, AG | 2017-02-23 | 258 | 0 |
| K162568 | INTRABEAM 600 | Carl Zeiss Meditec, AG | 2016-12-15 | 92 | 0 |
| K150467 | Retina Workplace | Carl Zeiss Meditec, AG | 2015-05-21 | 87 | 0 |
| K141844 | RESCAN 700, CALLISTO EYE | Carl Zeiss Meditec, AG | 2014-11-18 | 133 | 0 |
| K141297 | FORUM GLAUCOMA WORKPLACE | Carl Zeiss Meditec, AG | 2014-10-03 | 137 | 0 |
| K141068 | ZEISS CATARACT SUITE MARKERLESS | Carl Zeiss Meditec, AG | 2014-09-09 | 138 | 0 |
| K133217 | CIRRUS PHOTO | Carl Zeiss Meditec, AG | 2014-03-19 | 152 | 0 |
| K133476 | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION | Carl Zeiss Meditec, AG | 2014-02-12 | 92 | 0 |
| K130648 | FORUM GLAUCOMA WORKPLACE | Carl Zeiss Meditec, AG | 2013-07-23 | 134 | 0 |
| K122418 | IOLMASTER 500 | Carl Zeiss Meditec, AG | 2013-04-12 | 247 | 4 |
| K123464 | CALLISTO EYE | Carl Zeiss Meditec, AG | 2013-03-05 | 116 | 0 |
| K122938 | FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATC | Carl Zeiss Meditec, AG | 2012-11-02 | 39 | 1 |
| K103056 | VISULAS TRION LASER SYSTEM WITH THE VITE OPTION | Carl Zeiss Meditec, AG | 2011-02-01 | 109 | 0 |
| K101182 | IOLMASTER 500 | Carl Zeiss Meditec, AG | 2010-11-03 | 190 | 4 |
| K100253 | VISUMAX LASER KERATOME | Carl Zeiss Meditec, AG | 2010-07-08 | 161 | 1 |
| K100035 | MODEL VISULAS 532S LASER WITH THE VITE OPTION | Carl Zeiss Meditec, AG | 2010-03-17 | 70 | 0 |
| K072514 | VISULAS TRION | Carl Zeiss Meditec, AG | 2007-09-21 | 14 | 0 |
| K062314 | HORUS LASER KERATOME | Carl Zeiss Meditec, AG | 2006-12-22 | 136 | 0 |
| K052268 | VISUCAM PRO NM | Carl Zeiss Meditec, AG | 2005-11-02 | 75 | 0 |
| K043222 | VISCUCAM C DIGITAL CAMERA | Carl Zeiss Meditec, AG | 2005-02-14 | 84 | 0 |
| K042139 | VISULAS YAG III | Carl Zeiss Meditec, AG | 2004-09-09 | 31 | 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