K241239 is an FDA 510(k) clearance for the OrganProtex HTK Solution. This device is classified as a Set, Perfusion, Kidney, Disposable (Class II - Special Controls, product code KDL).
Submitted by Bridge TO Life, Ltd. (Northbrook, US). The FDA issued a Cleared decision on January 24, 2025, 266 days after receiving the submission on May 3, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K241239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2024 |
| Decision Date | January 24, 2025 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDL — Set, Perfusion, Kidney, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |