# K201046: Automated ankle brachial pressure index measuring device, MESI mTABLET system

- Pathway: 510(k) (Traditional)
- Applicant: Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
- Decided: Dec 11, 2020 after 234 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: 4 generations back to K002186 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172655: Automated ankle brachial pressure index measuring device, Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. (2018) Summary page 4.

## Indications for use
The MESI mTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). MESI mTABLET ABI is intended for the rapid measurement of ankle-brachial pressure index (ABI) and pulse 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 compression therapy. MESI mTABLET ABI can be used on patients with unilateral lower limb amputation. The MESI mTABLET ABI is intended to be used to spot-check patients. The MESI mTABLET ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

Source page: https://510kreport.com/device/K201046
Methodology: https://510kreport.com/methodology