Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Disior, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
358 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253764 | ENOS Software Guided External Fixation System | Disior, Ltd. | 2026-02-26 | 93 | 0 |
| K250023 | SMART PCFD | Disior, Ltd. | 2025-09-29 | 269 | 0 |
| K240736 | SMART Bun-Yo-Matic X-Ray | Disior, Ltd. | 2024-07-02 | 106 | 0 |
| K240642 | SMART Bun-Yo-Matic CT | Disior, Ltd. | 2024-06-20 | 106 | 0 |
| K223757 | Bonelogic | Disior, Ltd. | 2023-12-08 | 358 | 0 |
| K203290 | Bonelogic | Disior, Ltd. | 2021-02-05 | 88 | 0 |
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