# K212529: Hypotension Decision Assist Model HDA-OR2

- Pathway: 510(k) (Special)
- Applicant: Directed Systems, Ltd.
- Decided: Nov 23, 2021 after 104 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: 3 generations back to K072735 (2007). 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)
- K190955: Hypotension Decision Assist, Directed Systems, Ltd. (2019) Summary page 4.

## Indications for use
Hypotension Decision Assist is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their arterial pressure is being continuously monitored by a vital-signs monitor. It is indicated for use to assist anesthesia healthcare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery.

Source page: https://510kreport.com/device/K212529
Methodology: https://510kreport.com/methodology