Dio Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Dio Medical Co., Ltd.” (first 2010, latest 2023), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Since 2017 the median was 76 days, against 84 days for all cleared 510(k)s in the same product codes. 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 | 2 | 133 |
| 2013 | 1 | 162 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 105 |
| 2017 | 1 | 128 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 5 | 59 |
| 2023 | 1 | 80 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dio Medical Co., Ltd. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 84 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| PEK | Spinous Process Plate | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent Dio Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223790 | Huvex Interspinous Fusion System | PEK | 2023-03-09 | 80 |
| K223140 | AEON-C Stand Alone System | OVE | 2022-12-20 | 77 |
| K222415 | Rexious Spinal Fixation System | NKB | 2022-10-25 | 76 |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System | KWQ | 2022-10-18 | 54 |
| K222448 | UNITY Sacroiliac Joint Fixation System | OUR | 2022-10-13 | 59 |
| K222515 | FaSet Fixation System | MRW | 2022-10-05 | 47 |
| K162849 | Huvex Interspinous Fixation System | PEK | 2017-02-16 | 128 |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage | ODP | 2016-11-21 | 105 |
| K122872 | INTERVERTEBRAL BODY FUSION DEVICE | ODP | 2013-02-28 | 162 |
| K121862 | REX ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2012-10-31 | 127 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dio Medical 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 Dio Medical Co., Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Dio Medical Co., Ltd.” (first 2010, latest 2023), across 10 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 Dio Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dio Medical Co., Ltd. is 80 days. Since 2017: 76 days, versus 84 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dio Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2); PEK (Spinous Process Plate, 2).
Next steps
- See all 13 Dio Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Dio Medical 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.