Disior, Ltd.: FDA clearances and approvals
Disior, Ltd. has 6 FDA 510(k) clearances (first 2021, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 106 days. Since 2017 its median was 106 days, against 131 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 88 |
| 2022 | 0 | — |
| 2023 | 1 | 358 |
| 2024 | 2 | 106 |
| 2025 | 1 | 269 |
| 2026 | 1 | 93 |
Review time against the same product codes
Since 2017, Disior, Ltd.'s cleared 510(k)s took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| OSN | Software For Diagnosis/Treatment | 1 | 1 |
Review panels
- Radiology (5)
- Orthopedic (1)
Most recent Disior, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253764 | ENOS Software Guided External Fixation System | OSN | 2026-02-26 | 93 |
| K250023 | SMART PCFD | QIH | 2025-09-29 | 269 |
| K240736 | SMART Bun-Yo-Matic X-Ray | QIH | 2024-07-02 | 106 |
| K240642 | SMART Bun-Yo-Matic CT | QIH | 2024-06-20 | 106 |
| K223757 | Bonelogic | QIH | 2023-12-08 | 358 |
| K203290 | Bonelogic | LLZ | 2021-02-05 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Disior, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Disior, Ltd. have?
Disior, Ltd. has 6 FDA 510(k) clearances (first 2021, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear Disior, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Disior, Ltd.'s cleared 510(k)s is 106 days. Since 2017: 106 days, versus 131 days for all cleared 510(k)s in the same product codes.
What devices does Disior, Ltd. make?
Its most frequent FDA product codes are QIH (Automated Radiological Image Processing Software, 4); LLZ (System, Image Processing, Radiological, 1); OSN (Software For Diagnosis/Treatment, 1).
Has Disior, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Disior, Ltd. Related entities may recall under other names.
Next steps
- See all 6 Disior, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QIH, Disior, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.