# K170790: SAM CRRT Unit, SAM Cassette CRRT

- Pathway: 510(k) (Abbreviated)
- Applicant: Spectral Medical, Inc.
- Decided: Dec 13, 2017 after 272 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K062090 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110823: Prismaflex, Gambro Renal Products, Inc. (2011) Summary page 4.

## Indications for use
The S.A.M CRRT Unit is intended for: * Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. * Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers’ specifications. All treatments administered via the S.A.M unit must be prescribed by a physician and are intended to be performed in the environment of the Intensive Care Unit or Emergency Department of the hospital. Rx Only. The S.A.M Cassette CRRT is intended for single use in continuous renal replacement and therapeutic plasma exchange therapies using the S.A.M CRRT Unit. The S.A.M Cassette for CRRT is indicated for patients weighing 20 kg or more. Rx Only.

Source page: https://510kreport.com/device/K170790
Methodology: https://510kreport.com/methodology