Carl Zeiss Meditec, AG: FDA clearances and approvals
Carl Zeiss Meditec, AG has 46 FDA 510(k) clearances (first 2004, latest 2026), plus 2 PMA decisions, across 15 product codes in 4 review panels. Median 510(k) review time: 136 days. Since 2017 its median was 187 days, against 114 days for all cleared 510(k)s in the same product codes. openFDA lists 11 product recalls by a recalling firm named Carl Zeiss Meditec, AG. It is the industry lead sponsor of 22 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 39 |
| 2013 | 3 | 134 |
| 2014 | 5 | 137 |
| 2015 | 1 | 87 |
| 2016 | 1 | 92 |
| 2017 | 6 | 206 |
| 2018 | 4 | 134 |
| 2019 | 2 | 302 |
| 2020 | 1 | 193 |
| 2021 | 1 | 254 |
| 2022 | 3 | 284 |
| 2023 | 4 | 86 |
| 2024 | 3 | 154 |
| 2025 | 1 | 259 |
| 2026 | 1 | 136 |
Review time against the same product codes
Since 2017, Carl Zeiss Meditec, AG's cleared 510(k)s took a median 187 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | 11 | 11 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 8 | 8 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| HQF | Laser, Ophthalmic | 4 | 4 |
| OBO | Tomography, Optical Coherence | 4 | 4 |
| GWG | Endoscope, Neurological | 3 | 3 |
| HQC | Unit, Phacofragmentation | 3 | 3 |
| HKI | Camera, Ophthalmic, Ac-Powered | 2 | 2 |
| JAD | System, Therapeutic, X-Ray | 2 | 2 |
| QFX | Diagnostic Neurosurgical Microscope Filter | 2 | 2 |
Plus 5 more product codes.
Review panels
- Ophthalmic (34)
- Neurology (5)
- General and Plastic Surgery (5)
- Radiology (4)
Most recent Carl Zeiss Meditec, AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260694 | ZEISS CLINIC 360 | NFJ | 2026-07-17 | 136 |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | JAD | 2025-01-10 | 259 |
| K233911 | VISULAS combi | HQF | 2024-09-06 | 269 |
| K240215 | BLUE 400; BLUE 400 S | QFX | 2024-06-28 | 154 |
| K233421 | RESCAN 700 | OBO | 2024-03-08 | 150 |
| K232944 | CALLISTO eye | NFJ | 2023-12-21 | 92 |
| K232159 | QEVO System | GWG | 2023-09-21 | 63 |
| K231676 | CALLISTO eye | NFJ | 2023-08-28 | 80 |
| K230858 | QUATERA 700 | HQC | 2023-07-31 | 124 |
| K213527 | FORUM | NFJ | 2022-08-15 | 284 |
36 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990048 | PMA | ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER | 2000-04-12 |
| P830056 | PMA | STYLES 31-34 POSTERIOR IOLS | 1986-03-28 |
Recalls
11 product recalls in 9 recall events; 2 initiated in the last five years. Most recent: 2026-06-01.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Carl Zeiss Meditec, AG is the industry lead sponsor of 22 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT07092020: Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL) (Recruiting, started 2025-10-01)
- NCT07084545: Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens (Recruiting, started 2025-07)
- NCT06428955: Evaluation of a Monofocal Intraocular Lens (Recruiting, started 2024-06-06)
- NCT06111222: Visual Performance of Patients Implanted With a Multifocal IOL (Active not recruiting, started 2023-10-31)
- NCT06247683: Study to Confirm Safety and Performance of a New Multifocal IOL (Completed, started 2023-03-13)
Frequently asked questions
How many FDA 510(k) clearances does Carl Zeiss Meditec, AG have?
Carl Zeiss Meditec, AG has 46 FDA 510(k) clearances (first 2004, latest 2026), plus 2 PMA decisions, across 15 product codes in 4 review panels.
How long does FDA take to clear Carl Zeiss Meditec, AG's 510(k)s?
The median time from FDA receipt to decision across Carl Zeiss Meditec, AG's cleared 510(k)s is 136 days. Since 2017: 187 days, versus 114 days for all cleared 510(k)s in the same product codes.
What devices does Carl Zeiss Meditec, AG make?
Its most frequent FDA product codes are NFJ (System, Image Management, Ophthalmic, 11); HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 8); GEX (Powered Laser Surgical Instrument, 4).
Has Carl Zeiss Meditec, AG had device recalls?
openFDA lists 11 product recalls in 9 recall events by a recalling firm whose name matches Carl Zeiss Meditec, AG; the most recent began 2026-06-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 46 Carl Zeiss Meditec, AG clearances with predicates and recalls
- Run predicate analysis for product code NFJ, Carl Zeiss Meditec, AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.