# K121108: Dopplex Ability

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare
- Decided: Jan 3, 2013 after 266 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: 1 generation back to K002186 (2001). 1 ancestor in all.
5 later devices descend from it; 1 cites 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)
- K002186: Vascular Assist, Huntleigh Healthcare, Inc. (2001) Summary page 1.

## Most influential descendants
- K143152: TM-ABI system (2015), 4 descendants of its own
- 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
Dopplex Ability is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). Dopplex Ability 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. It is suitable for use in woundcare 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. Dopplex Ability can be used on patients with unilateral lower limb amputation.

Source page: https://510kreport.com/device/K121108
Methodology: https://510kreport.com/methodology