# K122281: Padnet 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Biomedix, Inc.
- Decided: Aug 29, 2012 after 30 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: 3 generations back to K973644 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073146: Padnet+, Biomedix, Inc. (2007) Summary page 1.

## Most influential descendants
- K220527: PADnet Xpress (2022), 0 descendants of its own

## Indications for use
The BioMedix PADnet 2.0 is a non-invasive device used to assess the lower and upper extremity arterial and venous circulatory systems in order to assist in the identification of vascular disease. To assess the arterial system, PADnet 2.0 uses pulse volume recording, arterial pulse contour analysis, and segmental systolic & diastolic blood pressure measurements. To assess the venous valvular system, PADnet 2.0 measures venous refilling time. For identification of venous obstruction in the deep venous (below knee) system, PADnet 2.0 measures venous outflow rate. It is intended to be used by healthcare professionals in a hospital or clinic 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/K122281
Methodology: https://510kreport.com/methodology