# K082758: Prismaflo II

- Pathway: 510(k) (Special)
- Applicant: Stihler Electronic GmbH
- Decided: Dec 19, 2008 after 91 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020103 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020103: Prismaflo, Stihler Electronic GmbH (2002) Summary page 1.
- K071909: Prismacomfort, Model  Autocontrol 3XPT with Autoline XPT 4R, Barkey GmbH & Co. KG (2007) Summary page 1.

## Recalls of this device
- Sep 6, 2018 · Class II · Z-0759-2019: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
- Sep 6, 2018 · Class II · Z-0761-2019: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
- Sep 6, 2018 · Class II · Z-0760-2019: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn

## Indications for use
For warming dialysis fluids and returning blood flow.

Source page: https://510kreport.com/device/K082758
Methodology: https://510kreport.com/methodology