# K140412: ANS1 Software

- Pathway: 510(k) (Special)
- Applicant: Ld Technology, LLC
- Decided: May 22, 2014 after 93 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K001907 (2000). 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)
- K113264: Electro Sensor Complex Software (ES Complex Software), Ld Technology, LLC (2012)

## Indications for use
ANSI Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer) When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANSI software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management. The ANSI software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results. The device provides values. It is the physician responsibility to make proper judgment based on these numbers. The ANSI software data are stored in back up files located on the PC. The software is intended for use only with adult subjects.

Source page: https://510kreport.com/device/K140412
Methodology: https://510kreport.com/methodology