Oculo Plastik, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Oculo Plastik, Inc.” (first 1990, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | 7 | 7 |
| HQX | Implant, Orbital, Extra-Ocular | 5 | 5 |
Review panels
- Ophthalmic (12)
Most recent Oculo Plastik, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112176 | SILICONE SPHERES | HPZ | 2011-09-15 | 49 |
| K073293 | DURETTE IMPLANT | HPZ | 2008-03-19 | 117 |
| K040689 | EYE SPHERE IMPLANTS | HPZ | 2004-06-10 | 86 |
| K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT | HPZ | 1994-05-05 | 209 |
| K915630 | OPHTIMPLANT | HPZ | 1992-03-02 | 76 |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | HQX | 1990-05-22 | 81 |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | HQX | 1990-05-18 | 80 |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | HQX | 1990-05-15 | 77 |
| K900928 | COX MALAR EMINENCE IMPLANTS | HQX | 1990-05-15 | 77 |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | HQX | 1990-05-15 | 77 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oculo Plastik, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Oculo Plastik, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Oculo Plastik, Inc.” (first 1990, latest 2011), across 2 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 Oculo Plastik, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oculo Plastik, Inc. is 78 days.
Which FDA product codes appear under Oculo Plastik, Inc.?
The most frequent FDA product codes under this applicant name are HPZ (Implant, Eye Sphere, 7); HQX (Implant, Orbital, Extra-Ocular, 5).
Next steps
- See all 12 Oculo Plastik, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HPZ, Oculo Plastik, 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.