# K220527: PADnet Xpress

- Pathway: 510(k) (Special)
- Applicant: Collaborative Care Diagnostics, LLC, D.B.A. Biomedix
- Decided: Oct 20, 2022 after 238 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: 4 generations back to K973644 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122281: Padnet 2.0, Biomedix, Inc. (2012) Summary page 4.

## Indications for use
The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professionals in either a professional medical or home environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.

Source page: https://510kreport.com/device/K220527
Methodology: https://510kreport.com/methodology