Servator P SALF Solution with THAM
FDA 510(k) K202652 · S.A.L.F. Spa
510(k) numberK202652
Submission
- Device name
- Servator P SALF Solution with THAM
- Applicant
- S.A.L.F. Spa
Cenate Sotto, IT - Received
- September 14, 2020
- Decision date
- August 19, 2021
- 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 |
|---|---|---|---|
| K261644 | Perfadex PlusKDN · Traditional | Xvivo Perfusion AB | 07/23/2026SE |
| 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 |
More from Paragonix Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K230193 | Servator P Plus SALF SolutionKDN · Traditional | 09/21/2023SE |
| K211842 | Servator M SALF SolutionKDL · Traditional | 12/20/2021SE |
| K190063 | Servator C SALF SolutionMSB · Traditional | 08/14/2019SE |
| K180481 | Servator B SALF SolutionKDN · Traditional | 06/29/2018SE |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC…KDL · Traditional | 10/20/2017SE |
Questions and answers
When was Servator P SALF Solution with THAM cleared by the FDA?
Servator P SALF Solution with THAM (K202652) received a 510(k) decision of Substantially Equivalent on August 19, 2021, 339 days after the submission was received.
What is the product code of K202652?
The FDA product code is KDN – System, Perfusion, Kidney, a Class II (moderate risk) device regulated under 21 CFR 876.5880.