K243618 is an FDA 510(k) clearance for the EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250). This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Bridge TO Life (Northbrook, US). The FDA issued a Cleared decision on June 17, 2025, 207 days after receiving the submission on November 22, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K243618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2024 |
| Decision Date | June 17, 2025 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDN - System, Perfusion, Kidney |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |