Konan Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Konan Medical, Inc.” (first 1995, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 211 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 | 1 | 72 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 288 |
| 2021 | 1 | 224 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Konan Medical, Inc. took a median 256 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQE | Microscope, Specular | 4 | 4 |
| NFJ | System, Image Management, Ophthalmic | 2 | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (7)
Most recent Konan Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203244 | CellChek 20 rc | NFJ | 2021-06-15 | 224 |
| K191558 | Konan Specular Microscope XVII | NQE | 2020-03-26 | 288 |
| K120264 | KONAN SPECULAR MICROSCOPE XIV | NQE | 2012-04-11 | 72 |
| K081797 | IMAGE STORAGE SYSTEM, MODEL KSS-400 | NFJ | 2009-01-22 | 211 |
| K062763 | NONCON ROBO PACHY F&A | NQE | 2008-02-22 | 525 |
| K040373 | KERATO ANALYZER (EKA) | NQE | 2004-03-19 | 31 |
| K950091 | KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 | HKI | 1995-03-01 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Konan Medical, Inc..
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.
- Konan, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Konan Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Konan Medical, Inc.” (first 1995, latest 2021), across 3 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 Konan Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Konan Medical, Inc. is 211 days.
Which FDA product codes appear under Konan Medical, Inc.?
The most frequent FDA product codes under this applicant name are NQE (Microscope, Specular, 4); NFJ (System, Image Management, Ophthalmic, 2); HKI (Camera, Ophthalmic, Ac-Powered, 1).
Next steps
- See all 7 Konan Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NQE, Konan Medical, Inc.'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.