Coopervision-Cilco: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Coopervision-Cilco” (first 1988, latest 1988), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 53 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KYB | Lens, Guide, Intraocular | 1 | 1 |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | 1 | 0 |
Review panels
- Ophthalmic (2)
- Radiology (1)
Most recent Coopervision-Cilco 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883489 | KRATZ NOVA SERT(TM) | KYB | 1988-10-25 | 70 |
| K882805 | CILCO VILLASENOR PACHYMETER | IYO | 1988-08-12 | 36 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P840047 | PMA | CILCO ND:YAG LASER | 1985-08-02 |
Recalls
openFDA lists no recalls under a recalling firm named Coopervision-Cilco.
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 Coopervision-Cilco?
FDA lists 2 510(k) clearances under the applicant name “Coopervision-Cilco” (first 1988, latest 1988), plus 1 PMA decision, across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Coopervision-Cilco?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coopervision-Cilco is 53 days.
Which FDA product codes appear under Coopervision-Cilco?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1); KYB (Lens, Guide, Intraocular, 1); LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla, 1).
Next steps
- See all 2 Coopervision-Cilco clearances with predicates and recalls
- Run predicate analysis for product code IYO, Coopervision-Cilco'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.