Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scopio Labs , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) App | Scopio Labs , Ltd. | 2025-06-27 | 270 | 0 |
| DEN230034 | X100 with Full Field Bone Marrow Aspirate (BMA) Application | Scopio Labs , Ltd. | 2024-03-22 | 329 | 0 |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Sm | Scopio Labs , Ltd. | 2022-05-03 | 119 | 0 |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Applicatio | Scopio Labs , Ltd. | 2020-10-02 | 140 | 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