# K970629: Tango Non-Invasive Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Suntech Medical Instruments, Inc.
- Decided: Jan 2, 1998 after 317 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System (2006), 13 descendants of its own
- 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

## Indications for use
The Tango Blood Pressure Monitor is intended for use as an aid or adjunct to ECG exercise stress testing, measuring and displaying an adult patients systolic and diastolic blood pressures. The Tango Monitor has two operating modes, Dimensional K-Sound (DKA) and Oscillometry. In the Oscillometric mode the Tango NIBP monitor measures: 1. Systolic Pressure (mmHg) 2. Diastolic Pressure (mmHg) 3. Pulse Rate (beats per minute) In the Dimensional K-Sound mode (DKA) the Tango NIBP monitor measures: 1. Systolic Pressure (mmHg) 2. Diastolic Pressure (mmHg) 3. Heart Rate (beats per minute) Depending on the mode the Monitor is in one of the following waveforms are displayed: 1. R-Wave trigger signal (DKA) 2. K-sound waveforms (DKA) 3. or Oscillometric pressure pulses (Oscillometric) Intended Patient Population The Tango NIBP-monitor-is-only-intended for use as a stress tes€ monitor. The unitis not intended for use with children, neonates or geriatrics. The Tango monitor is limited to adult use, the age range for the unit is 18 and older. Arm swcs are limited to the following cuff sizes: Small Adult 18cm - 26 cm Adult 25cm - 35cm Large Adult 33cm-47 cm Intended Operators and Environment The Tango NIBP monitor is intended to be operated by a nurse, physician or clinician for stress/exercise tests. The Tango is only intended to be used in a hospital, clinic and stress test lab. There are no circumstances were the Tango NIBP monitorwould be operated by a patient or outside of hospital, clinic or stress test lab. The Tango has been tested and meets the environmental operating conditions required by AAMI SP10. Refer to Appendix B1 for the AAMI SP10 test results.

Source page: https://510kreport.com/device/K970629
Methodology: https://510kreport.com/methodology