# K122401: Tango M2 Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Suntech Medical, Inc.
- Decided: Nov 2, 2012 after 87 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: 7 generations back to K910772 (1991). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System, Suntech Medical, Inc. (2006) Summary page 1.
- K970629: Tango Non-Invasive Blood Pressure Monitor, Suntech Medical Instruments, Inc. (1998) Summary page 1.

## Indications for use
The SunTech Medical Tango M2 NIBP monitor with optional Pulse Oximeter is indicated for use in measuring and displaying blood pressure, heart rate, functional oxygen saturation of arterial hemoglobin (5p02) of adult patients in hospitals, medical facilities, and subacute environments.

Source page: https://510kreport.com/device/K122401
Methodology: https://510kreport.com/methodology