# K011625: Vasocor Vascular Diagnostic Center (Model 300)

- Pathway: 510(k) (Traditional)
- Applicant: Vasocor, Inc.
- Decided: Jan 23, 2002 after 243 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 K961144 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961144: MS-2000, Touritu Engineering Co., Inc. (1997) Summary page 1.
- K001948: Cvprofilor D0-2020 Cardiovascular Profiling System, Hypertension Diagnostics, Inc. (2000) Summary page 1.

## Indications for use
The Vasocor™ Vascular Diagnostic Center (Model 300) is a non-invasive medical device that can be used by physicians and other health care professionals to measure blood pressure values (systolic, diastolic and pulse pressure) and the heart pulse rates based on segmental measurement. The Vascular Diagnostic Center (Model 300) also calculates Framingham coronary heart disease, stroke, and peripheral disease risk scores, body mass index (BMI), ankle/brachial index (ABI), and pressure differentials between certain adjacent peripheral limb segments, and provides indications of arterial compliance. The indications of arterial compliance (that is, elasticity indices) can be used to assist in assessing and managing patients that may have potential underlying vascular disease, including cardiovascular disease, that might require more specific diagnostic evaluations by physicians or other health care providers.

Source page: https://510kreport.com/device/K011625
Methodology: https://510kreport.com/methodology