KDL
- Product code
- KDL
- Device name
- Set, Perfusion, Kidney, Disposable
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5880
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 19 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241239 | 2025-01-24 | Bridge TO Life, Ltd. | OrganProtex HTK Solution | FDA |
Official FDA classification page: KDL
Classification and pathway per current FDA publications. Data from openFDA (CC0).