# K031153: Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Nov 25, 2003 after 228 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K851426 (1985). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972798: Dynemo 3000, Sometec, Inc. (1998) Summary page 1.

## Most influential descendants
- K040802: Hemosonic 200HEMODYNAMIC Monitor (2004), 0 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K031153
Methodology: https://510kreport.com/methodology