Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243618 FDA 510(k)
- FDA Product Code
- KDN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5880 FDA 510(k)
- Regulation Number
- 876.5880 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is a sterile, isotonic 0.9% sodium chloride solution designed for preparing slushed solutions. It is intended for use in maintaining hypothermia during the recovery, storage, and transport of donor organs for transplantation, as well as during open surgical procedures such as cardiovascular, abdominal, and transplant surgeries. The solution is non-pyrogenic and contained in a sterile, flexible, non-PVC bag.
This device is supplied as a single-use, sterile solution and is regulated under FDA 510(k) clearance (K243618) with a classification of Class II (KDN). It is intended for use in clinical settings where controlled hypothermia is required, such as organ transplantation and specific surgical procedures. The product adheres to regulatory standards for sterile medical solutions and is intended for one-time use only.
Frequently asked questions
What clinical procedures is the EasiSlush® Sodium Chloride Solution primarily used for preparing slushed solutions during?
The EasiSlush® Sodium Chloride Solution is designed for preparing slushed solutions to maintain hypothermia during organ transplantation—specifically for donor organs like kidneys—during recovery, storage, and transport. It is also used in open surgical procedures such as cardiovascular, abdominal, and transplant surgeries where controlled hypothermia is required.
Is the EasiSlush® Sodium Chloride Solution reusable, or is it intended for single-use only?
The EasiSlush® Sodium Chloride Solution is explicitly labeled as a single-use device. This ensures sterility and safety, as it is provided in a sterile, flexible, non-PVC bag and is not intended for reuse.
How is the EasiSlush® Sodium Chloride Solution packaged and stored to maintain its sterility?
The solution comes in a sterile, flexible, non-PVC bag, which helps preserve its sterility. Since it is a single-use product, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for optimal storage conditions to maintain its integrity.
What regulatory pathway was followed for the FDA clearance of the EasiSlush® Sodium Chloride Solution?
The EasiSlush® Sodium Chloride Solution received FDA clearance through a 510(k) submission (K243618) under the Traditional review pathway. It was determined to be Substantially Equivalent (SESE) to a predicate device and is classified as Class II (KDN) under FDA regulations.
What types of medical specialties or procedures are most commonly associated with the use of this solution?
The solution is primarily associated with gastroenterology and urology procedures, as indicated by its regulatory submissions. However, it is also used in cardiovascular, abdominal, and transplant surgeries, particularly where controlled hypothermia is critical—such as during organ preservation and recovery for transplantation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EasiSlush® Slush Preparation Instructions | Bridge to Life LTD, PDF EasiSlush®, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243618 | Class II | Active |
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Manufacturer
- Manufacturer
- Bridge TO Life
Sources (1)
- FDA 510(k) K243618 24 fields · synced Sep 20, 2026