K240650 is an FDA 510(k) clearance for the LungProtect, a System, Perfusion, Kidney (Class II — Special Controls, product code KDN), submitted by Traferox Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on November 26, 2024, 264 days after receiving the submission on March 7, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K240650 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 2024 |
| Decision Date | November 26, 2024 |
| Days to Decision | 264 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 |