# K172655: Automated ankle brachial pressure index measuring device

- Pathway: 510(k) (Traditional)
- Applicant: Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
- Decided: Jan 11, 2018 after 128 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 K002186 (2001). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143152: TM-ABI system, Ld Technology, LLC (2015) Summary page 4.

## Most influential descendants
- K201046: Automated ankle brachial pressure index measuring device, MESI mTABLET system (2020), 0 descendants of its own
- K191266: VitalScan ANS (2020), 0 descendants of its own

## Indications for use
The ABPI MD system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). The ABPI MD system is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI) and pulse volume recording (PVR)/volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of conipression therapy. The ABPI MD system can be used on patients with unilateral lower limb amputation. The ABPI MD system is intended to be used to spot-check patients. The ABPI MD systein provides information regarding patient risk. The physician has the responsibility of making proper judgements based on this information.

Source page: https://510kreport.com/device/K172655
Methodology: https://510kreport.com/methodology