Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Axial Medical Printing Limited · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

220 daysmedian FDA review time
294 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250369Axial3D InsightAxial Medical Printing Limited2025-09-182200
K231607Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited2024-01-242370
K232841Axial3D InsightAxial Medical Printing Limited2023-11-15620
K222745Axial3D InsightAxial Medical Printing Limited2023-07-032940
K221511Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited2022-06-23300

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda