Fci Ophthalmics, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Fci Ophthalmics, Inc.” (first 1996, latest 2006), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| OKS | Lacrimal Stents And Intubation Sets | 4 | 4 |
| LZU | Plug, Punctum | 3 | 3 |
| HPZ | Implant, Eye Sphere | 2 | 2 |
| HQX | Implant, Orbital, Extra-Ocular | 2 | 2 |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | 1 | 1 |
| MQU | Ocular Peg | 1 | 1 |
Review panels
- Ophthalmic (13)
Most recent Fci Ophthalmics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061404 | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE | OKS | 2006-08-07 | 80 |
| K061398 | SNUG PLUG PUNCTUM PLUG | LZU | 2006-07-11 | 53 |
| K041869 | SELF RETAINING BICANALICULUS INTUBATION SET | OKS | 2004-11-18 | 132 |
| K023758 | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | OKS | 2003-09-17 | 313 |
| K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | HPZ | 2003-08-22 | 317 |
| K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | HJK | 2003-02-26 | 51 |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | HPZ | 2000-04-19 | 287 |
| K991238 | FCI CRAWFORD PROBE INTUBATION SETS | OKS | 1999-07-08 | 87 |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | HQX | 1998-09-18 | 199 |
| K980822 | TITANIUM PEG SYSTEM | MQU | 1998-07-09 | 128 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fci Ophthalmics, 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 Fci Ophthalmics, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Fci Ophthalmics, Inc.” (first 1996, latest 2006), 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 Fci Ophthalmics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fci Ophthalmics, Inc. is 87 days.
Which FDA product codes appear under Fci Ophthalmics, Inc.?
The most frequent FDA product codes under this applicant name are OKS (Lacrimal Stents And Intubation Sets, 4); LZU (Plug, Punctum, 3); HPZ (Implant, Eye Sphere, 2).
Next steps
- See all 13 Fci Ophthalmics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OKS, Fci Ophthalmics, 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.