Chiron Vision Corp.: FDA clearances and approvals
Chiron Vision Corp. has 34 FDA 510(k) clearances (first 1980, latest 1997), across 17 product codes in 3 review panels. Median 510(k) review time: 92 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 15 | 15 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 | 2 |
| HNO | Keratome, Ac-Powered | 2 | 2 |
| KYB | Lens, Guide, Intraocular | 2 | 2 |
| FCT | Headlight, Fiberoptic Focusing | 1 | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 | 1 |
| HMR | Marker, Ocular | 1 | 1 |
| HMS | Drum, Eye Knife Test | 1 | 1 |
| HMX | Cannula, Ophthalmic | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Plus 7 more product codes.
Review panels
- Ophthalmic (30)
- Dental (2)
- General Hospital (1)
Most recent Chiron Vision Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970727 | MPORT FOLDABLE LENS PLACEMENT SYSTEM | MSS | 1997-12-17 | 292 |
| K972808 | HANSATOME MICROKERATOME | HNO | 1997-10-24 | 88 |
| K960414 | SYNERGIST POWER PACK | HQC | 1996-04-24 | 86 |
| K944993 | IOLAB.SITE CD PHACOEMULSIFICATION MODULE | HQC | 1995-10-12 | 365 |
| K944995 | IOLAB/SITE PERISTALTIC MODULE | HQC | 1995-10-05 | 358 |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | KYB | 1995-06-02 | 72 |
| K944994 | IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE | HQC | 1995-03-14 | 153 |
| K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT | HNO | 1994-11-22 | 237 |
| K935233 | IOLAB LACRIMAL DUCT CATHETER | OKS | 1994-09-15 | 318 |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | HMR | 1994-08-29 | 662 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chiron Vision Corp..
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 Chiron Vision Corp. have?
Chiron Vision Corp. has 34 FDA 510(k) clearances (first 1980, latest 1997), across 17 product codes in 3 review panels.
How long does FDA take to clear Chiron Vision Corp.'s 510(k)s?
The median time from FDA receipt to decision across Chiron Vision Corp.'s cleared 510(k)s is 92 days.
What devices does Chiron Vision Corp. make?
Its most frequent FDA product codes are HQC (Unit, Phacofragmentation, 15); EKX (Handpiece, Direct Drive, Ac-Powered, 2); HNO (Keratome, Ac-Powered, 2).
Has Chiron Vision Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Chiron Vision Corp. Related entities may recall under other names.
Next steps
- See all 34 Chiron Vision Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Chiron Vision Corp.'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.