Bridge TO Life, Ltd.: FDA clearances and approvals
Bridge TO Life, Ltd. has 6 FDA 510(k) clearances (first 2019, latest 2025), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time: 184 days. Since 2017 its median was 184 days, against 182 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Bridge TO Life, Ltd. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 161 |
| 2020 | 0 | — |
| 2021 | 1 | 238 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 4 | 179 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bridge TO Life, Ltd.'s cleared 510(k)s took a median 184 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDN | System, Perfusion, Kidney | 5 | 5 |
| KDL | Set, Perfusion, Kidney, Disposable | 1 | 1 |
| SGY | Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant | 1 | 0 |
Review panels
Most recent Bridge TO Life, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | KDN | 2025-06-17 | 207 |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | KDN | 2025-03-31 | 151 |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | KDN | 2025-03-26 | 103 |
| K241239 | OrganProtex HTK Solution | KDL | 2025-01-24 | 266 |
| K203262 | Cannula for Organ Perfusion | KDN | 2021-07-01 | 238 |
| K191006 | EasiSlush | KDN | 2019-09-24 | 161 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250009 | De Novo | Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant | 2026-01-15 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-06-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Bridge TO Life, Ltd. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07578441: VitaSmart HOPE System: Bridge to HOPE Registry (Enrolling by invitation, started 2026-09)
- NCT05045794: Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation (Completed, started 2021-12-16)
Frequently asked questions
How many FDA 510(k) clearances does Bridge TO Life, Ltd. have?
Bridge TO Life, Ltd. has 6 FDA 510(k) clearances (first 2019, latest 2025), plus 1 De Novo decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Bridge TO Life, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Bridge TO Life, Ltd.'s cleared 510(k)s is 184 days. Since 2017: 184 days, versus 182 days for all cleared 510(k)s in the same product codes.
What devices does Bridge TO Life, Ltd. make?
Its most frequent FDA product codes are KDN (System, Perfusion, Kidney, 5); KDL (Set, Perfusion, Kidney, Disposable, 1); SGY (Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant, 1).
Has Bridge TO Life, Ltd. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Bridge TO Life, Ltd; the most recent began 2025-06-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Bridge TO Life, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KDN, Bridge TO Life, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.