Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Monteris Medical · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
239 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260976 | NeuroBlate System | Monteris Medical | 2026-04-23 | 30 | 0 |
| K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024-06-04 | 67 | 0 |
| K231061 | NeuroBlate System | Monteris Medical, | 2023-12-08 | 239 | 0 |
| K222983 | NeuroBlate Fusion-S Software V3.17 | Monteris Medical, | 2023-03-15 | 168 | 0 |
| K193375 | NeuroBlate System | Monteris Medical, | 2020-01-03 | 29 | 0 |
| K182036 | NeuroBlate System | Monteris Medical, | 2018-10-15 | 77 | 0 |
| K173305 | NeuroBlate System | Monteris Medical, | 2017-11-17 | 30 | 0 |
| K172881 | NeuroBlate System | Monteris Medical, | 2017-10-20 | 29 | 0 |
| K170724 | NeuroBlate System | Monteris Medical, | 2017-04-07 | 29 | 0 |
| K132444 | ATAMA SYSTEM | Monteris Medical, | 2014-01-27 | 174 | 0 |
| K090240 | MONTERIS MEDICAL UFO | Monteris Medical, | 2009-08-06 | 185 | 0 |
| K081509 | MONTERIS MEDICAL AUTOLITT LASER PROBE | Monteris Medical, | 2009-05-01 | 337 | 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