# K112521: Fukuda Denshi Vasera Model VS-1500

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Dec 21, 2011 after 112 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: 3 generations back to K872291 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013434: VP-2000/1000, Colin Corp. (2002) Summary page 3.
- K964187: Fukada Denshi Dynascope Model DS-5300 Patient Monitor, Fukuda Denshi USA, Inc. (1997) Summary page 2.

## Indications for use
The Fukuda Denshi VaSera model VS-1500AU is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measuring non-invasive blood pressures, heart rate, pulse volume recordings and heart sounds. The device also has the capability of calculating ANI (Ankle Brachial Index), TBI (Toe Brachial Index), and pulse wave velocity measurements. The device is intended to be used under the order of a physician, in hospitals, doctor's offices, clinics or other medical facilities where non-invasive peripheral vascular tests are performed. The device is intended to be used on adult population only. The device is not intended for home use.

Source page: https://510kreport.com/device/K112521
Methodology: https://510kreport.com/methodology