# K071909: Prismacomfort, Model  Autocontrol 3XPT with Autoline XPT 4R

- Pathway: 510(k) (Abbreviated)
- Applicant: Barkey GmbH & Co. KG
- Decided: Oct 18, 2007 after 99 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020103 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K082758: Prismaflo II (2008), 0 descendants of its own
- K082765: Astoflo Plus (2008), 0 descendants of its own

## Indications for use
The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment.

Source page: https://510kreport.com/device/K071909
Methodology: https://510kreport.com/methodology