Perfadex Plus
FDA 510(k) K261644 · Xvivo Perfusion AB
510(k) numberK261644
Submission
- Device name
- Perfadex Plus
- Applicant
- Xvivo Perfusion AB
Mölndal, SE - Received
- May 18, 2026
- Decision date
- July 23, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDN – System, Perfusion, Kidney
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5880
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KDN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260456 | VI°Port Liver Preservation SystemKDN · Traditional | Traferox Technologies, Inc. | 06/01/2026SE |
| K254305 | BAROguard Donor Lung Preservation SystemKDN · Special | Paragonix Technologies, Inc. | 01/30/2026SE |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)KDN · Traditional | Bridge TO Life | 06/17/2025SE |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation SolutionKDN · Traditional | Traferox Technologies, Inc. | 05/01/2025SE |
| K243998 | DCX Disposable Cassette (DCX)KDN · Traditional | Institut Geroges Lopez | 04/25/2025SE |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001)KDN · Traditional | Bridge TO Life | 03/31/2025SE |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)KDN · Traditional | Bridge TO Life | 03/26/2025SE |
| K240650 | LungProtectKDN · Traditional | Traferox Technologies, Inc. | 11/26/2024SE |
| K234060 | KIDNEYvault Portable Renal Perfusion SystemKDN · Traditional | Paragonix Technologies | 10/23/2024SE |
| K230193 | Servator P Plus SALF SolutionKDN · Traditional | S.A.L.F. Spa | 09/21/2023SE |
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Questions and answers
When was Perfadex Plus cleared by the FDA?
Perfadex Plus (K261644) received a 510(k) decision of Substantially Equivalent on July 23, 2026, 66 days after the submission was received.
What is the product code of K261644?
The FDA product code is KDN – System, Perfusion, Kidney, a Class II (moderate risk) device regulated under 21 CFR 876.5880.