# K220281: multiFiltratePRO System

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Dec 16, 2022 after 318 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: 7 generations back to K910215 (1991). 30 ancestors in all.
No later device cites it as a predicate yet.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163530: PrisMax Control Unit, Baxter Healthcare Corp (2017) Summary page 4.
- K042938: Gambro Prismaflex HF1000 and HF1400 Sets, Gambro Renal Products (2005) Summary page 4.

## Indications for use
The multiFiltratePRO System is indicated for the following use: Continuous Renal Replacement Therapy (CRRT) for patients weighing 40 kilograms or more with acute renal failure with or without fluid overload. All treatments administered by the multiFiltratePRO System must be prescribed by a physician.

Source page: https://510kreport.com/device/K220281
Methodology: https://510kreport.com/methodology