Chiron Ophthalmics: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Chiron Ophthalmics” (first 1988, latest 1992), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| MOE | Collagen Corneal Shield | 6 | 6 |
| HQL | Intraocular Lens | 2 | 1 |
| KYB | Lens, Guide, Intraocular | 2 | 2 |
| LYX | Media, Corneal Storage | 1 | 1 |
Review panels
- Ophthalmic (11)
Most recent Chiron Ophthalmics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915861 | MEDILENS-CS CORNEAL SHIELD | MOE | 1992-03-06 | 66 |
| K914311 | CHIROFLEX II LENS MICROSERT(TM) | HQL | 1992-01-27 | 123 |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | MOE | 1991-06-10 | 161 |
| K903575 | CHIROFLEX FORCEPS | KYB | 1990-12-21 | 135 |
| K903574 | CHIROFLEX LENS MICROSERT | KYB | 1990-09-17 | 40 |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | MOE | 1990-07-02 | 67 |
| K894162 | OPTISOL | LYX | 1990-01-12 | 212 |
| K885015 | COI 72 HR COLLAGEN SHIELD | MOE | 1989-06-23 | 200 |
| K885016 | COI 24 HR COLLAGEN SHIELD | MOE | 1989-02-01 | 58 |
| K882762 | COLLAGEN SHIELD | MOE | 1988-09-12 | 68 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890068 | PMA | MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL | 1990-01-11 |
Recalls
openFDA lists no recalls under a recalling firm named Chiron Ophthalmics.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Chiron Vision Corp. (34 510(k)s)
- Chiron Diagnostics Corp. (20 510(k)s)
- Chiron Intraoptics (4 510(k)s)
- Chiron Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Chiron Ophthalmics?
FDA lists 10 510(k) clearances under the applicant name “Chiron Ophthalmics” (first 1988, latest 1992), plus 1 PMA decision, 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 Chiron Ophthalmics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chiron Ophthalmics is 96 days.
Which FDA product codes appear under Chiron Ophthalmics?
The most frequent FDA product codes under this applicant name are MOE (Collagen Corneal Shield, 6); HQL (Intraocular Lens, 2); KYB (Lens, Guide, Intraocular, 2).
Next steps
- See all 10 Chiron Ophthalmics clearances with predicates and recalls
- Run predicate analysis for product code MOE, Chiron Ophthalmics'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.