510(k) · Cleared
ClearedTango+ Automatic Blood Pressure and Oxygen Saturation Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suntech Medical, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jan 5, 2006 as substantially equivalent to K970629 (Suntech Medical Instruments, Inc., 1998) and 1 other predicate after a 50-day review. Its family tree reaches back 6 generations to 1991. 13 later devices descend from it.
- Decided
- Jan 5, 2006
- Review
- 50 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K910772 (1991). 21 ancestors in all, the oldest K893221 (1990). 13 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 1 generation backK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- This deviceK053209 Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement…Suntech Medical, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK063814 BP-200 PlusSchiller AG · 2007
- Descendant · 2 generations on · 4 of its ownK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
- Descendant · 3 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 4 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK060820 Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc. · 2006
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K063814BP-200 PlusSchiller AG · 2007 · cites it directly7descendants
- K101619Welch Allyn 1500 Patient MonitorSchiller AG · 2010 · 2 generations on4descendants
- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 3 generations on3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 4 generations on2descendants
- K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc. · 2006 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −5 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −1 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| 0 (this device) | K053209 | Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System | Suntech Medical, Inc. | 2006 | — |
| +1 | K063814 | BP-200 Plus | Schiller AG | 2007 | — |
| +2 | K101619 | Welch Allyn 1500 Patient Monitor | Schiller AG | 2010 | — |
| +3 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +4 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +1 | K060820 | Cycle BP Monitor and Pulse Oximeter, Model 1060 | Suntech Medical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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 summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970629 | Tango Non-Invasive Blood Pressure MonitorSummary page 1…blood pressure, non-invasive, systolic and/or diastolic, 74J0E, 870.1130 (3) Legally-marketed predicate devices SunTech Tango, K970629 Nonin Avant 2120, K03 1487 SunTech Medical Page 5-2 (3) Description tile Tango+, a m… | 1998 |
| * | K031487 | Model Avant 2120 Pulse Oximeter and NibpSummary page 1…e, systolic and/or diastolic, 74J0E, 870.1130 (3) Legally-marketed predicate devices SunTech Tango, K970629 Nonin Avant 2120, K03 1487 SunTech Medical Page 5-2 (3) Description tile Tango+, a microprocessor based ambulator… | 2004 |
What descends from it? (13)
See all 134 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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K063814 (Schiller AG, 2007) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K970629.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053209
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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