Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eximo Medical, Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
255 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Cathet | Eximo Medical, Ltd. | 2024-06-27 | 27 | 1 |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating ( | Eximo Medical, Ltd. | 2023-12-15 | 30 | 0 |
| K230709 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2023-06-09 | 87 | 0 |
| K220116 | Auryon Atherectomy Catheters | Eximo Medical, Ltd. | 2022-09-26 | 255 | 0 |
| K221077 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2022-06-09 | 58 | 0 |
| K202835 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2020-12-02 | 68 | 0 |
| K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018-10-05 | 106 | 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