Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stereotactic Medical Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
131 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896156 | COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM | Stereotactic Medical Systems, Inc. | 1989-12-06 | 43 | 0 |
| K884415 | EP-100 (SERIES) | Stereotactic Medical Systems, Inc. | 1989-02-28 | 131 | 0 |
| K883653 | EP-100 INFUSION PUMP | Stereotactic Medical Systems, Inc. | 1988-11-01 | 67 | 0 |
| K871046 | COMPASS STEREOTACTIC POSITIONING SYSTEM | Stereotactic Medical Systems, Inc. | 1987-05-08 | 52 | 0 |
| K862220 | COMPASS CT STEREOTACTIC ADAPTATION SYSTEM | Stereotactic Medical Systems, Inc. | 1986-06-18 | 7 | 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