# K061557: Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Medwave, Inc.
- Decided: Sep 15, 2006 after 102 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K011152 (2001). 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)
- K011152: Vasotrac APM205A, Medwave, Inc. (2001) Summary page 1.

## Indications for use
The FusionTM System and accessories blood pressure measurement system is intended to be used on patients with wrist circumference of 11 cm - 22 cm by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure and pulse rate. The Fusion System module option of Nellcor OxiMAX Option (K012891), is indicated for the continuous non-invasive monitoring of a patient's functional oxygen saturation of arterial hemoglobin (SpO2) by trained medical personnel. The Fusion System module option of Kendall Genius Thermometer (K920713) is indicated for the measuring of a patient's body temperature. This device is prescription use only.

Source page: https://510kreport.com/device/K061557
Methodology: https://510kreport.com/methodology