# K131860: Vasculab VL4000 Photoplethysmograph with Pulse Volume Recording

- Pathway: 510(k) (Traditional)
- Applicant: Us Vascular, LLC
- Decided: Sep 27, 2013 after 95 days
- Product code: JOP (Transducer, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 870.2880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904392 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111416: Falcon, Viasonix, Ltd. (2011) Summary page 1.

## Indications for use
The VL4Oxx is a Non-Invasive diagnostic system designed to detect peripheral vascular pathology in adults. In all cases the intended use is for spot checking and attended use by trained medical professionals in a hospital or medical facility by the order of a medical doctor. The VL4Oxx is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

Source page: https://510kreport.com/device/K131860
Methodology: https://510kreport.com/methodology