Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ONO · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
129 daysmedian FDA review time
266 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260976 | NeuroBlate System | Monteris Medical | 2026-04-23 | 30 | 0 |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualas | Medtronic Navigation, Inc. | 2026-03-13 | 164 | 0 |
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N | Clinical Laserthermia Systems, AB | 2025-09-04 | 129 | 0 |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation | 2025-05-29 | 115 | 0 |
| K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024-06-04 | 67 | 0 |
| K214125 | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | 2022-09-22 | 266 | 0 |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022-01-07 | 255 | 1 |
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