# K173696: TBL-ABI System

- Pathway: 510(k) (Special)
- Applicant: Ld Technology, LLC
- Decided: Dec 19, 2017 after 18 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults 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. TBL-ABI can be used on patients with unilateral lower limb amputation. The TBL-ABI System is intended to be used to spot-check patients. The TBL-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/K173696
Methodology: https://510kreport.com/methodology