Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bridge TO Life — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Prepar | Bridge TO Life | 2025-06-17 | 207 | 0 |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life | 2025-03-31 | 151 | 0 |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | 2025-03-26 | 103 | 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