Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sage Biopharma · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
272 daysmedian FDA review time
300 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003734 | SERUM PROTEIN SUBSTITUTE | Sage Biopharma | 2000-12-21 | 17 | 0 |
| K002836 | MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE | Sage Biopharma | 2000-10-03 | 21 | 0 |
| K991396 | WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L | Sage Biopharma | 2000-02-15 | 300 | 0 |
| K991393 | HYALURONIDASE, 80 U/ML | Sage Biopharma | 2000-02-02 | 287 | 0 |
| K991390 | 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCRO | Sage Biopharma | 2000-01-18 | 272 | 2 |
| K991378 | PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE W | Sage Biopharma | 1999-09-24 | 156 | 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