# K093205: Padcheck

- Pathway: 510(k) (Traditional)
- Applicant: Padtest, LLC
- Decided: Apr 1, 2010 after 170 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K872291 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042616: Biomedix Padnet Lab, Biomedix, Inc. (2004) Summary page 1.
- K013434: VP-2000/1000, Colin Corp. (2002) Summary page 1.

## Indications for use
The PADChek ABI/PVR is a non-invasive device used to a94ist in the detection of peripheral artery disease (PAD). Pressure measurements at the ankles (dorsalis pedis and/or posterior tibialis arteries) are compared to the highest pressure in either arm (brachial arteries) and a ABI (Ankle Brachial Index) is calculated. A P'ulse Volume Recording (PVR) is simultaneously performed to determine the presence of blood flow. 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. Tt is also not intended for use on or near non intact skin.

Source page: https://510kreport.com/device/K093205
Methodology: https://510kreport.com/methodology