# K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Suntech Medical, Inc.
- Decided: Jan 5, 2006 after 50 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: 6 generations back to K910772 (1991). 21 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970629: Tango Non-Invasive Blood Pressure Monitor, Suntech Medical Instruments, Inc. (1998) Summary page 1.
- K031487: Model Avant 2120 Pulse Oximeter and Nibp, Nonin Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K063814: BP-200 Plus (2007), 7 descendants of its own
- K101619: Welch Allyn 1500 Patient Monitor (2010), 4 descendants of its own
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K060820: Cycle BP Monitor and Pulse Oximeter, Model 1060 (2006), 2 descendants of its own

## Indications for use
The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.

Source page: https://510kreport.com/device/K053209
Methodology: https://510kreport.com/methodology