Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biosphere Medical, S.A. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
320 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | 2025-05-16 | 46 | 0 |
| K192480 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | 2019-11-21 | 72 | 0 |
| K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2019-08-06 | 270 | 0 |
| K183578 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | 2019-06-18 | 179 | 0 |
| K181021 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2018-09-27 | 163 | 0 |
| K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018-07-16 | 60 | 0 |
| K172372 | QuadraSphere Microspheres | Biosphere Medical, S.A. | 2017-09-06 | 30 | 0 |
| DEN160040 | Embosphere Microspheres | Biosphere Medical, S.A. | 2017-06-21 | 320 | 0 |
| K153102 | QuadraSphere Microspheres | Biosphere Medical, S.A. | 2015-11-23 | 28 | 0 |
| K151187 | QuadraSphere Microspheres | Biosphere Medical, S.A. | 2015-07-27 | 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