Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bridge TO Life, Ltd. · 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) |
|---|---|---|---|---|---|
| DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | Bridge TO Life, Ltd. | 2026-01-15 | 290 | 0 |
| K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | 2025-01-24 | 266 | 0 |
| K203262 | Cannula for Organ Perfusion | Bridge TO Life, Ltd. | 2021-07-01 | 238 | 0 |
| K191006 | EasiSlush | Bridge TO Life, Ltd. | 2019-09-24 | 161 | 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