# K110628: Simpleabi

- Pathway: 510(k) (Traditional)
- Applicant: Newman Medical
- Decided: May 12, 2011 after 70 days
- Product code: JAF (Monitor, Ultrasonic, Nonfetal)
- Device class: 2
- Regulation: 21 CFR 892.1540
- 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 K090465 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090465: Digdop Ultrasound System, The Newman Group, LLC (2009) Summary page 6.

## Indications for use
The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional Information for the clinician. PVR is used as a plethysmograph to measure the change In limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler Is problematic. The unit will calculate Ankle Brachial index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.

Source page: https://510kreport.com/device/K110628
Methodology: https://510kreport.com/methodology