# K042616: Biomedix Padnet Lab

- Pathway: 510(k) (Traditional)
- Applicant: Biomedix, Inc.
- Decided: Oct 12, 2004 after 19 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 K973644 (1997). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 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.

## Most influential descendants
- K073146: Padnet+ (2007), 2 descendants of its own
- K122281: Padnet 2.0 (2012), 1 descendant of its own
- K220527: PADnet Xpress (2022), 0 descendants of its own
- K103693: Vantage Abi (2011), 0 descendants of its own
- K093205: Padcheck (2010), 0 descendants of its own

## Indications for use
The BioMedix PADnet Lab is a non invasive device used to record physiological data from the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures for use by the Physician in the identification of vascular pathology. 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 use on or near non intact skin.

Source page: https://510kreport.com/device/K042616
Methodology: https://510kreport.com/methodology