Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)

K-Number: K243618 · 2025-06-17

ApplicantBridge TO Life
Decision Date2025-06-17
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is a medical device manufactured by Bridge TO Life. It received FDA 510(k) clearance on 2025-06-17 under approval number K243618. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)?

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is a medical device that received FDA 510(k) clearance on 2025-06-17. It is manufactured by Bridge TO Life. The 510(k) number is K243618.

When was EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) approved by the FDA?

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) received FDA 510(k) clearance on 2025-06-17, under approval number K243618.

What company makes EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)?

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is manufactured by Bridge TO Life.

What is the FDA product code for EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)?

The FDA product code for EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is KDN.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT04559334 Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients SUSPENDED

Other Devices by Bridge TO Life

K243384Belzer UW® Cold Storage Solution (BTLBUW-001) K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

Related Devices (Code: KDN)

K153384Low Potassium Dextran Solution with Tris DiluentUnited Therapeutics Corporation K180481Servator B SALF SolutionS.A.L.F. Spa K170826Perfadex PlusXvivo Perfusion AB K191440Paragonix SherpaPak Pancreas Transport SystemParagonix Technologies K191006EasiSlushBridge TO Life, Ltd. K201048SherpaPak Pediatric Liver Transport SystemParagonix Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑