Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ORR · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181195 | ClearPoint System | Mri Interventions, Inc. | 2018-11-02 | 182 | 0 |
| K171257 | ClearPoint System | Mri Interventions, Inc. | 2017-10-20 | 175 | 0 |
| K111073 | SURGIVISION INC. CLEARPOINT SYSTEM | Surgi-Vision, Inc. | 2011-06-22 | 65 | 0 |
| K100836 | CLEARPOINT SYSTEM | Surgivision, Inc. | 2010-06-16 | 84 | 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