Carl Zeiss Meditec Cataract Technology, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Carl Zeiss Meditec Cataract Technology, Inc.” (first 2019, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 261 days. Since 2017 the median was 261 days, against 197 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under ZEISS Medical Technology, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 117 |
| 2020 | 2 | 204 |
| 2021 | 0 | — |
| 2022 | 2 | 145 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 274 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Carl Zeiss Meditec Cataract Technology, Inc. took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 197 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 7 | 7 |
Review panels
- Ophthalmic (7)
Most recent Carl Zeiss Meditec Cataract Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243395 | MICOR 700 with Auto I/A | HQC | 2025-08-08 | 281 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | HQC | 2025-06-11 | 267 |
| K214028 | MICOR Lens Fragmentation System | HQC | 2022-09-09 | 261 |
| K222236 | miCOR System Lens Fragmentation System | HQC | 2022-08-24 | 29 |
| K200207 | xPORT S Lens Fragmentation System | HQC | 2020-10-15 | 261 |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | HQC | 2020-07-31 | 147 |
| K191024 | xPORT Lens Fragmentation System | HQC | 2019-08-13 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Carl Zeiss Meditec Cataract Technology, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Carl Zeiss Meditec, AG (46 510(k)s)
- Carl Zeiss, Inc. (44 510(k)s)
- Carl Zeiss Meditec, Inc. (30 510(k)s)
- Carl Parker Associates, Inc. (7 510(k)s)
- Carl Zeiss Surgical GmbH (4 510(k)s)
- Carl Zeiss Ophthalmic Systems, Inc. (2 510(k)s)
- Carl Zeiss Suzhou Co., Ltd. (2 510(k)s)
- Carl Schuh (1 510(k)s)
- Carl Zeiss Jena GmbH (1 510(k)s)
- Carl Zeiss Vision GmbH (1 510(k)s)
- Carl Zeiss Meditec Production, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carl Zeiss Meditec Cataract Technology, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Carl Zeiss Meditec Cataract Technology, Inc.” (first 2019, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carl Zeiss Meditec Cataract Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carl Zeiss Meditec Cataract Technology, Inc. is 261 days. Since 2017: 261 days, versus 197 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Carl Zeiss Meditec Cataract Technology, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 7).
Next steps
- See all 7 Carl Zeiss Meditec Cataract Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Carl Zeiss Meditec Cataract Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.