# K172431: Cardiovascular Analzyer

- Pathway: 510(k) (Traditional)
- Applicant: Physiowave, Inc.
- Decided: Mar 14, 2018 after 215 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K903134 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122129: Sphygmocor Xcel, Atcor Medical (2012) Summary page 5.
- (no number) Detecto Solo® scale: named in the summary without a submission number

## Indications for use
The Cardiovascular Analyzer is intended to obtain Pulse Wave Velocity (PWV) and Pulse Rate (PR) through a combination of impedance plethysmography and weight measurements in adults 18 years of age and older. The Cardiovascular Analyzer also measures Body Weight and calculates BMI.

Source page: https://510kreport.com/device/K172431
Methodology: https://510kreport.com/methodology