Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgivision, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102101 | SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA | Surgivision, Inc. | 2011-01-26 | 183 | 0 |
| K100836 | CLEARPOINT SYSTEM | Surgivision, Inc. | 2010-06-16 | 84 | 0 |
| K091343 | MRI NEURO DRAPE | Surgivision, Inc. | 2009-09-22 | 139 | 0 |
| K091439 | HEAD FIXATION ARC AND TABLE BASE | Surgivision, Inc. | 2009-08-25 | 103 | 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