Axial Medical Printing Limited: FDA clearances and approvals
Axial Medical Printing Limited has 5 FDA 510(k) clearances (first 2022, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time: 220 days. Since 2017 its median was 220 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 |
|---|---|---|
| 2022 | 1 | 30 |
| 2023 | 2 | 178 |
| 2024 | 1 | 237 |
| 2025 | 1 | 220 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Axial Medical Printing Limited's cleared 510(k)s took a median 220 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 | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Radiology (5)
Most recent Axial Medical Printing Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250369 | Axial3D Insight | QIH | 2025-09-18 | 220 |
| K231607 | Axial3D Cloud Segmentation Service | LLZ | 2024-01-24 | 237 |
| K232841 | Axial3D Insight | QIH | 2023-11-15 | 62 |
| K222745 | Axial3D Insight | QIH | 2023-07-03 | 294 |
| K221511 | Axial3D Cloud Segmentation Service | LLZ | 2022-06-23 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Axial Medical Printing Limited.
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 Axial Medical Printing Limited have?
Axial Medical Printing Limited has 5 FDA 510(k) clearances (first 2022, latest 2025), across 2 product codes in 1 review panel.
How long does FDA take to clear Axial Medical Printing Limited's 510(k)s?
The median time from FDA receipt to decision across Axial Medical Printing Limited's cleared 510(k)s is 220 days. Since 2017: 220 days, versus 131 days for all cleared 510(k)s in the same product codes.
What devices does Axial Medical Printing Limited make?
Its most frequent FDA product codes are QIH (Automated Radiological Image Processing Software, 3); LLZ (System, Image Processing, Radiological, 2).
Has Axial Medical Printing Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Axial Medical Printing Limited. Related entities may recall under other names.
Next steps
- See all 5 Axial Medical Printing Limited clearances with predicates and recalls
- Run predicate analysis for product code QIH, Axial Medical Printing Limited'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.