Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biosphere Medical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
403 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113822 | QUADRASPHERE 30 TO 60 | Biosphere Medical, Inc. | 2012-03-08 | 72 | 0 |
| K052742 | HEPASPHERE MICROSPHERES | Biosphere Medical, Inc. | 2006-11-07 | 403 | 0 |
| K062126 | EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP- | Biosphere Medical, Inc. | 2006-08-09 | 14 | 0 |
| K061171 | SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX | Biosphere Medical, Inc. | 2006-06-02 | 36 | 0 |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN | Biosphere Medical, Inc. | 2002-11-22 | 204 | 0 |
| K010026 | EMBOGOLD MICROSPHERE | Biosphere Medical, Inc. | 2001-06-21 | 169 | 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