# K143152: TM-ABI system

- Pathway: 510(k) (Traditional)
- Applicant: Ld Technology, LLC
- Decided: Jul 22, 2015 after 261 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 K002186 (2001). 2 ancestors in all.
4 later devices descend from it; 2 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)
- K121108: Dopplex Ability, Huntleigh Healthcare (2013) Summary page 4.

## Most influential descendants
- K172655: Automated ankle brachial pressure index measuring device (2018), 2 descendants of its own
- 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
- K173696: TBL-ABI System (2017), 0 descendants of its own

## Indications for use
The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TM-ABI 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 the application of compression therapy. TM-ABI system can be used on patients with unilateral lower limb amputation. The TM-ABI System is intended to be used to spot-check patients. The TM-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/K143152
Methodology: https://510kreport.com/methodology