# K232788: Inspira ART100

- Pathway: 510(k) (Traditional)
- Applicant: Inspira Technologies Oxy B.H.N., Ltd.
- Decided: May 24, 2024 after 256 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- 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 K991864 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991864: Rotaflow Centrifugal Pump System, Jostra Medizintechnik AG (2000) Summary page 4.

## Indications for use
The INSPIRA ART100 system is intended for use in an extra corporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Source page: https://510kreport.com/device/K232788
Methodology: https://510kreport.com/methodology