Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carl Zeiss Meditec Cataract Technology, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
281 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-08-08 | 281 | 0 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 70 | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-06-11 | 267 | 0 |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-09-09 | 261 | 0 |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-08-24 | 29 | 0 |
| K200207 | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-10-15 | 261 | 0 |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-07-31 | 147 | 0 |
| K191024 | xPORT Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2019-08-13 | 117 | 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