# K062090: Prisma System R03.10A

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Oct 18, 2006 after 86 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“10810”).
- (no number) Prisma System V 3.03: named in the summary without a submission number

## Most influential descendants
- K110823: Prismaflex (2011), 1 descendant of its own
- K170790: SAM CRRT Unit, SAM Cassette CRRT (2017), 0 descendants of its own

## Indications for use
The Prisma® System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated.

Source page: https://510kreport.com/device/K062090
Methodology: https://510kreport.com/methodology