# K973659: Vasocor PVR 100

- Pathway: 510(k) (Traditional)
- Applicant: Vasocor, Inc.
- Decided: Dec 17, 1997 after 83 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
Longest line of descent: 1 generation back to K832679 (1984). 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)
- K832679: Non-Invasive Clinical Vascular Lab, Life Sciences Manufacturing, Inc. (1984) Summary page 2.

## Indications for use
The Vasocor PVR-100 (Pulse Volume Recorder) is a non-invasive medical device used in conjunction with other devices such as; continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of limbs and digits. Use of the PVR in this manner allows the physician to non-invasively diagnosis extremity arterial and venous disorders.

Source page: https://510kreport.com/device/K973659
Methodology: https://510kreport.com/methodology