# K040802: Hemosonic 200HEMODYNAMIC Monitor

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: Apr 28, 2004 after 30 days
- Product code: DPN (Thin Layer Chromatography, Propoxyphene)
- Device class: 2
- Regulation: 21 CFR 862.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K851426 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031153: Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065, Arrow Intl., Inc. (2003) Summary page 1.

## Indications for use
The HemoSonicTM 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.

Source page: https://510kreport.com/device/K040802
Methodology: https://510kreport.com/methodology