# K990123: PVR-100/Vasogram

- Pathway: 510(k) (Traditional)
- Applicant: Vasocor, Inc.
- Decided: Apr 12, 1999 after 89 days
- Product code: JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic)
- Device class: 2
- Regulation: 21 CFR 870.2780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PVR-100 / Vasogram is a noninvasive medical device used in conjunction with other devices such as: continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of the limbs and digits. Use of the PVR-100 / Vasogram in this manner allows the physician to noninvasively diagnosis extremity arterial and venous disorders, and receive, record, and produce a visual display of local arterial compliance.

Source page: https://510kreport.com/device/K990123
Methodology: https://510kreport.com/methodology