510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bridge to Life Ltd

Duluth, GA, US

Bridge to Life Ltd appears in FDA device records in Duluth, GA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Bridge to Life Ltd between 2019 and 2026. The busiest year on record is 2025, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bridge to Life Ltd, by decision year
YearClearances
20191
20211
20254
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
DEN250009VitaSmart Hypothermic Oxygenated Perfusion SystemSGYUnknown
K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)KDNSubstantially Equivalent
K243384Belzer UW® Cold Storage Solution (BTLBUW-001)KDNSubstantially Equivalent
K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)KDNSubstantially Equivalent
K241239OrganProtex HTK SolutionKDLSubstantially Equivalent
K203262Cannula for Organ PerfusionKDNSubstantially Equivalent
K191006EasiSlushKDNSubstantially Equivalent

Registered establishments

FDA registered establishments for Bridge to Life Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30318848333031884833Bridge to Life Ltd3300 Breckinridge Blvd., Suite 200, Duluth, GA 30096 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2157-2025Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain