# K134051: Transonic Elsa System

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Jan 29, 2015 after 394 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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 K960817 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960817: HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2), Transonic Systems, Inc. (1997) Summary page 4.
- K113821: Transonic Costatus Cardiac Output System, Transonic Systems, Inc. (2012) Summary page 4.

## Indications for use
The intended use of the ELSA system is to provide clinically relevant data to healthcare providers treating neonatal, pediatric, adult patients with arterial and venous lines for routine monitoring of diagnostic parameters: Delivered Flow; Recirculation; Oxygenator Blood Volume and other associated hemodynamic parameters.

Source page: https://510kreport.com/device/K134051
Methodology: https://510kreport.com/methodology