Ascon Medical Instruments, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ascon Medical Instruments, Ltd.” (first 1985, latest 1985), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| HPA | Frame, Trial, Ophthalmic | 2 | 2 |
| HLN | Gauge, Lens, Ophthalmic | 1 | 1 |
| HNR | Forceps, Ophthalmic | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| HPC | Set, Lens, Trial, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Ascon Medical Instruments, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852054 | CONTACT LENS LOUPE, INSPETION LOUPE | HLN | 1985-09-05 | 119 |
| K852055 | ASCON OPHTHALMIC SPONGE | HOZ | 1985-09-04 | 118 |
| K852548 | ATL 225 MW TRAIL LENS SET | HPA | 1985-07-31 | 49 |
| K852057 | ASCON SURGICAL INSTRUMENTS | HNR | 1985-06-27 | 49 |
| K852126 | ATF 101 TRAIL FRAME | HPA | 1985-06-05 | 21 |
| K852056 | ACC CROSS CYLINDERS | HPC | 1985-06-05 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Ascon Medical Instruments, Ltd..
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 Ascon Medical Instruments, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Ascon Medical Instruments, Ltd.” (first 1985, latest 1985), across 5 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 Ascon Medical Instruments, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ascon Medical Instruments, Ltd. is 49 days.
Which FDA product codes appear under Ascon Medical Instruments, Ltd.?
The most frequent FDA product codes under this applicant name are HPA (Frame, Trial, Ophthalmic, 2); HLN (Gauge, Lens, Ophthalmic, 1); HNR (Forceps, Ophthalmic, 1).
Next steps
- See all 6 Ascon Medical Instruments, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HPA, Ascon Medical Instruments, Ltd.'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.