510(k) · Cleared
ClearedTango Non-Invasive Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suntech Medical Instruments, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jan 2, 1998 after a 317-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.
- Decided
- Jan 2, 1998
- Review
- 317 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK970629 Tango Non-Invasive Blood Pressure MonitorSuntech Medical Instruments, Inc. · 1998
- Descendant · cites it directly · 13 of its ownK053209 Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement…Suntech Medical, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK063814 BP-200 PlusSchiller AG · 2007
- Descendant · 3 generations on · 4 of its ownK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
- Descendant · 4 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 5 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc. · 2006 · cites it directly13descendants
- K063814BP-200 PlusSchiller AG · 2007 · 2 generations on7descendants
- K101619Welch Allyn 1500 Patient MonitorSchiller AG · 2010 · 3 generations on4descendants
- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 4 generations on3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970629 | Tango Non-Invasive Blood Pressure Monitor | Suntech Medical Instruments, Inc. | 1998 | — |
| +1 | K053209 | Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System | Suntech Medical, Inc. | 2006 | — |
| +2 | K063814 | BP-200 Plus | Schiller AG | 2007 | — |
| +3 | K101619 | Welch Allyn 1500 Patient Monitor | Schiller AG | 2010 | — |
| +4 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +5 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053209 (Suntech Medical, Inc., 2006) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
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…
Read the full statement (271 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970629: Tango Non-Invasive Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970629
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026