Imedicom Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Imedicom Co., Ltd.” (first 2014, latest 2019), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 282 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 |
|---|---|---|
| 2014 | 1 | 126 |
| 2015 | 0 | — |
| 2016 | 4 | 325 |
| 2017 | 0 | — |
| 2018 | 1 | 282 |
| 2019 | 1 | 226 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 Imedicom Co., Ltd. took a median 254 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | 2 | 2 |
| HRX | Arthroscope | 2 | 2 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Imedicom Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182287 | MEDINAUT Plus | HRX | 2019-04-06 | 226 |
| K173541 | EPINAUT | BSO | 2018-08-24 | 282 |
| K153296 | MEDINAUT Kyphoplasty System | NDN | 2016-07-29 | 259 |
| K150915 | SPINAUT-P | GEI | 2016-03-18 | 347 |
| K151268 | SPINAUT-V, SPINAUT-S, SPINAUT-I | HRX | 2016-03-16 | 308 |
| K150789 | SPINAUT-E, SPINAUT-I | BSO | 2016-03-01 | 342 |
| K133669 | MEDINAUT KYPHOPLASTY SYSTEM | NDN | 2014-04-04 | 126 |
Recalls
openFDA lists no recalls under a recalling firm named Imedicom Co., 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 Imedicom Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Imedicom Co., Ltd.” (first 2014, latest 2019), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Imedicom Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imedicom Co., Ltd. is 282 days.
Which FDA product codes appear under Imedicom Co., Ltd.?
The most frequent FDA product codes under this applicant name are BSO (Catheter, Conduction, Anesthetic, 2); HRX (Arthroscope, 2); NDN (Cement, Bone, Vertebroplasty, 2).
Next steps
- See all 7 Imedicom Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BSO, Imedicom Co., 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.