# Bridge TO Life, Ltd.

- Location (FDA's records): Northbrook, IL
- FDA decisions: 7 (2019–2026): 6 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Bridge TO Life, Ltd. (4); Bridge TO Life (3)
- Product codes: KDN (5), SGY (1), KDL (1)
- 510(k) review time since 2016: median 179 days, against 135 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Preservation Solutions, Inc.: 3 (https://510kreport.com/company/preservation-solutions)
- Dr. Franz Kohler Chemie GmbH: 1 (https://510kreport.com/company/dr-franz-kohler-chemie)
- Organ Recovery Systems, Inc.: 1 (https://510kreport.com/company/organ-recovery-systems)
- Fresenius USA, Inc.: 1 (https://510kreport.com/company/fresenius-usa)

## Firms that cite its devices most
- TransMedics, Inc.: 1 (https://510kreport.com/company/transmedics)

## Its most-cited devices
- K191006: EasiSlush (2019), cited by 1
- K203262: Cannula for Organ Perfusion (2021), cited by 1

## Recent decisions
- DEN250009: VitaSmart Hypothermic Oxygenated Perfusion System (Jan 15, 2026)
- K243618: EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation  (BTLE-1250) (Jun 17, 2025)
- K243384: Belzer UW® Cold Storage Solution (BTLBUW-001) (Mar 31, 2025)
- K243840: Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (Mar 26, 2025)
- K241239: OrganProtex HTK Solution (Jan 24, 2025)
- K203262: Cannula for Organ Perfusion (Jul 1, 2021)
- K191006: EasiSlush (Sep 24, 2019)

Source page: https://510kreport.com/company/bridge-to-life
