Servator M SALF Solution
FDA 510(k) K211842 · S.A.L.F. Spa
510(k) numberK211842
Submission
- Device name
- Servator M SALF Solution
- Applicant
- S.A.L.F. Spa
Cenate Sotto, IT - Received
- June 15, 2021
- Decision date
- December 20, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDL – Set, Perfusion, Kidney, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5880
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KDL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241239 | OrganProtex HTK SolutionKDL · Traditional | Bridge TO Life, Ltd. | 01/24/2025SE |
| K221387 | BEL-GEN Cold Storage SolutionKDL · Traditional | Institut Georges Lopez | 06/14/2022SE |
| K221386 | PERF-GEN Pulsatile Perfusion SolutionKDL · Traditional | Institut Georges Lopez | 06/14/2022SE |
| K192408 | Custodiol HTK SolutionKDL · Traditional | Dr. Franz Kohler Chemie GmbH | 04/24/2020SE |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC…KDL · Traditional | S.A.L.F. Spa | 10/20/2017SE |
| K121736 | Perf-Gen Pulsatile Perfusion SolutionKDL · Traditional | Waters Medical Systems, LLC | 08/16/2013SE |
| K121618 | Bel-Gen Cold Storage SolutionKDL · Traditional | Waters Medical Systems, LLC | 06/14/2013SE |
| K091656 | SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2LKDL · Traditional | Organ Recovery Systems, Inc. | 03/11/2010SE |
| K043461 | CustodiolKDL · Traditional | Dr. Franz Kohler Chemie GmbH | 02/28/2005SE |
| K020924 | Custodiol HTK SolutionKDL · Traditional | Dr. Franz Kohler Chemie GmbH | 01/06/2003SE |
More from Dr. Franz Kohler Chemie GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K230193 | Servator P Plus SALF SolutionKDN · Traditional | 09/21/2023SE |
| K202652 | Servator P SALF Solution with THAMKDN · Traditional | 08/19/2021SE |
| 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 M SALF Solution cleared by the FDA?
Servator M SALF Solution (K211842) received a 510(k) decision of Substantially Equivalent on December 20, 2021, 188 days after the submission was received.
What is the product code of K211842?
The FDA product code is KDL – Set, Perfusion, Kidney, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5880.