Miami Eye Technology, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Miami Eye Technology, Inc.” (first 1983, latest 1984), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HKY | Tonometer, Manual | 1 | 1 |
| HNH | Ring, Ophthalmic (Flieringa) | 1 | 1 |
| HNY | Cystotome | 1 | 1 |
| HPN | Magnet, Permanent | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Miami Eye Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841101 | CLAYMAN-PAREL CAPSULE COUPEUR | HNY | 1984-05-16 | 64 |
| K832912 | GELENDER VACUUM FIXATION RING SYS | HNH | 1984-01-10 | 134 |
| K832996 | SURGICAL IOP MONITOR | HKY | 1983-11-28 | 87 |
| K832997 | EPA AUTOMATED INFUSION POLE | HQC | 1983-10-04 | 32 |
| K832911 | ABBOTT GLOBE HOLDER | HJO | 1983-09-29 | 31 |
| K831702 | RARE-EARTH INTRA-OCULAR MAGNET | HPN | 1983-06-30 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Miami Eye 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.
- Miami Device Solutions, LLC (7 510(k)s)
- Miami Fat Supply (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Miami Eye Technology, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Miami Eye Technology, Inc.” (first 1983, latest 1984), across 6 product codes 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 Miami Eye Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Miami Eye Technology, Inc. is 50 days.
Which FDA product codes appear under Miami Eye Technology, Inc.?
The most frequent FDA product codes under this applicant name are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 1); HKY (Tonometer, Manual, 1); HNH (Ring, Ophthalmic (Flieringa), 1).
Next steps
- See all 6 Miami Eye Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HJO, Miami Eye 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.