# K073146: Padnet+

- Pathway: 510(k) (Special)
- Applicant: Biomedix, Inc.
- Decided: Nov 21, 2007 after 13 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: 2 generations back to K973644 (1997). 2 ancestors in all.
2 later devices descend 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)
- K973644: Flostat Vascular Lab, Biomedix, Inc. (1997) Summary page 2.
- K042616: Biomedix Padnet Lab, Biomedix, Inc. (2004) Summary page 2.

## Most influential descendants
- K122281: Padnet 2.0 (2012), 1 descendant of its own
- K220527: PADnet Xpress (2022), 0 descendants of its own

## Indications for use
The BioMedix PADnet+ is a non invasive device used to gage the lower extremity arterial and venous system, using pulse volume recording, oscillometric segmental systolic blood pressure and photo plethysmograph, to assist in the identification of vascular disease. 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/K073146
Methodology: https://510kreport.com/methodology