Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Monteris Medical, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
402 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201056 | NeuroBlate System | Monteris Medical, Inc. | 2020-08-21 | 122 | 0 |
| K171255 | Monteris Medical NeuroBlate System | Monteris Medical, Inc. | 2017-07-25 | 88 | 1 |
| K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016-10-26 | 26 | 0 |
| K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015-02-19 | 78 | 1 |
| K131955 | NEUROBLATE(TM) SYSTEM | Monteris Medical, Inc. | 2013-07-30 | 33 | 2 |
| K131278 | MONTERIS MEDICAL NEUROBLATE SYSTEM | Monteris Medical, Inc. | 2013-07-11 | 66 | 1 |
| K120561 | NEUROBLATE SYSTEM | Monteris Medical, Inc. | 2013-04-01 | 402 | 1 |
| K110411 | ATAMA SYSTEM | Monteris Medical, Inc. | 2011-04-08 | 53 | 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