Cilco, Inc.: FDA clearances and approvals
Cilco, Inc. has 12 FDA 510(k) clearances (first 1982, latest 1986), across 10 product codes in 2 review panels. Median 510(k) review time: 76 days.
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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | 2 | 2 |
| HNR | Forceps, Ophthalmic | 1 | 1 |
| HNY | Cystotome | 1 | 1 |
| HPT | Perimeter, Automatic, Ac-Powered | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| KYB | Lens, Guide, Intraocular | 1 | 1 |
| LYX | Media, Corneal Storage | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (9)
- Radiology (1)
Most recent Cilco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861334 | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | HNN | 1986-05-02 | 23 |
| K854969 | CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) | IYO | 1986-02-27 | 78 |
| K844249 | K-SOL | LYX | 1985-04-30 | 179 |
| K843319 | CILCO I/A SURGICAL PACK | HQC | 1985-02-14 | 174 |
| K843992 | CILCOR OPHTHALMIC INSTRUMENTS | HNR | 1984-11-21 | 41 |
| K843447 | CILCO DIAMOND KNIFE | HNN | 1984-10-05 | 30 |
| K841099 | OCTOPUS 500/500E | HPT | 1984-06-19 | 99 |
| K840475 | CYSTOTOME, 140-S | HNY | 1984-04-05 | 62 |
| K832405 | OPTHALMIC ENDOSCOPE | — | 1983-11-21 | 123 |
| K827371 | CILCO ASCAN | — | 1982-07-09 | 102 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cilco, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cilco, Inc. have?
Cilco, Inc. has 12 FDA 510(k) clearances (first 1982, latest 1986), across 10 product codes in 2 review panels.
How long does FDA take to clear Cilco, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cilco, Inc.'s cleared 510(k)s is 76 days.
What devices does Cilco, Inc. make?
Its most frequent FDA product codes are HNN (Knife, Ophthalmic, 2); HNR (Forceps, Ophthalmic, 1); HNY (Cystotome, 1).
Has Cilco, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cilco, Inc. Related entities may recall under other names.
Next steps
- See all 12 Cilco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNN, Cilco, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.