# K020103: Prismaflo

- Pathway: 510(k) (Abbreviated)
- Applicant: Stihler Electronic GmbH
- Decided: Jul 24, 2002 after 194 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
No predicates in its family tree.
3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071909: Prismacomfort, Model  Autocontrol 3XPT with Autoline XPT 4R (2007), 2 descendants of its own
- K082758: Prismaflo II (2008), 0 descendants of its own
- K082765: Astoflo Plus (2008), 0 descendants of its own

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

Source page: https://510kreport.com/device/K020103
Methodology: https://510kreport.com/methodology