# K981681: Prisma CFM (Continuous Fluid Management System)

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Aug 11, 1998 after 90 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 7 cite it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013733: System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set (2002), 14 descendants of its own
- K032431: Prisma M60/M100 Sets (2003), 8 descendants of its own
- K021615: Baxter Accura System, Model 5M5660 (2002), 8 descendants of its own
- K040489: Aquadex System 100, Model A1100 (2004), 6 descendants of its own
- K050609: Aquadex System (2005), 5 descendants of its own

## Recalls of this device
- Oct 24, 2005 · Not classified · Z-0705-06: After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.

## Indications for use
The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician.

Source page: https://510kreport.com/device/K981681
Methodology: https://510kreport.com/methodology