Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biospace Med — 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) |
|---|---|---|---|---|---|
| K101398 | STEREOS WORKSTATION | Biospace Med | 2011-02-04 | 262 | 1 |
| K090050 | STEREOS WORKSTATION | Biospace Med | 2010-03-05 | 422 | 0 |
| K080529 | STEREOS WORKSTATION | Biospace Med | 2008-08-29 | 185 | 0 |
| K071546 | EOS | Biospace Med | 2007-09-18 | 104 | 1 |
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