# K063183: Prisma M10 Pre Set

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: Feb 15, 2007 after 119 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PRISMA M60 Set: named in the summary without a submission number
- (no number) Gambro FH 2211: named in the summary without a submission number

## Indications for use
The PRISMA MIO Pre Set is indicated for use with the PRISMA control unit only in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. The set is intended for use in the following veno-venous therapies: * slow continuous ultrafiltration (SCUF) * continuous veno-venous hemofiltration (CVVH) * continuous veno-venous hemodialysis (CVVHD) * continuous veno-venous hemodiafiltration (CVVHDF) The PRISMA M10 Pre Set is intended for treatment of neonates and infants with a body weight ranging between 2 and 15 kg.

Source page: https://510kreport.com/device/K063183
Methodology: https://510kreport.com/methodology