Cui Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cui Corp.” (first 1990, latest 1991), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 2 | 2 |
| FZE | Prosthesis, Nose, Internal | 2 | 2 |
| LZK | Implant, Malar | 2 | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 1 | 1 |
Review panels
Most recent Cui Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913140 | SILICONE GEL SHEETING | MDA | 1991-09-30 | 76 |
| K904350 | CUI DORSAL COLUMELLA PROSTHESIS | FZE | 1990-11-26 | 63 |
| K904349 | CUI CURVILINEAR SILICONE CHIN | FWP | 1990-11-26 | 63 |
| K904348 | CUI FEATHERED SILICONE MALAR | LZK | 1990-11-26 | 63 |
| K903329 | CUI ANATOMICAL SILICONE MALAR | LZK | 1990-09-10 | 47 |
| K903328 | CUI PREMAXILLARY IMPLANT | FZE | 1990-09-10 | 47 |
| K903327 | CUI ARTICULATED SILICONE CHIN | FWP | 1990-09-10 | 47 |
Recalls
openFDA lists no recalls under a recalling firm named Cui Corp..
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 Cui Corp.?
FDA lists 7 510(k) clearances under the applicant name “Cui Corp.” (first 1990, latest 1991), across 4 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 Cui Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cui Corp. is 63 days.
Which FDA product codes appear under Cui Corp.?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 2); FZE (Prosthesis, Nose, Internal, 2); LZK (Implant, Malar, 2).
Next steps
- See all 7 Cui Corp. clearances with predicates and recalls
- Run predicate analysis for product code FWP, Cui Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.