510(k) · Cleared
ClearedSunTech CT40 Spot-check Vital Signs Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suntech Medical · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 6, 2016 as substantially equivalent to K070750 (Suntech Medical, Inc., 2007) and 1 other predicate after a 140-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jul 6, 2016
- Review
- 140 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951193 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK951193 Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc. · 1996
- 3 generations backK024005 Welch Allyn Vital Sign Monitor with MP506Welch Allyn, Inc. · 2003
- 2 generations backK040490 Welch Allyn Spot Ultra Vital Signs DeviceWelch Allyn, Inc. · 2004
- 1 generation backK101680 Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesWelch Allyn, Inc. · 2010 · Recalled
- This deviceK160439 SunTech CT40 Spot-check Vital Signs DeviceSuntech Medical · 2016
- Descendant · cites it directly · 0 of its ownK192092 Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA…Seca GmbH & Co. KG · 2020
Most influential descendants
Showing 1 of 1 · See all- K192092Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535Seca GmbH & Co. KG · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951193 | Clinical Vital Signs Monitor, Model #52STP-E1 | Tycos Instruments, Inc. | 1996 | — |
| −3 | K024005 | Welch Allyn Vital Sign Monitor with MP506 | Welch Allyn, Inc. | 2003 | — |
| −2 | K040490 | Welch Allyn Spot Ultra Vital Signs Device | Welch Allyn, Inc. | 2004 | — |
| −1 | K101680 | Welch Allyn Spot Vital Signs Lxi Model 45000 Series | Welch Allyn, Inc. | 2010 | 2 |
| 0 (this device) | K160439 | SunTech CT40 Spot-check Vital Signs Device | Suntech Medical | 2016 | — |
| +1 | K192092 | Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 | Seca GmbH & Co. KG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K070750 | 247 BP DeviceSummary page 4…lood Pressure Measurement System, DXN 870.1130 (3) Legally-marketed predicate devices The CT40 (Model 260) is an updated version of SunTech's 247 Spot Check Device (K070750). It includes the same measurement parameters, NIBP, SpO2 and temperature, as the 247 device. The new CT40 (Model 260) has… | 2007 |
| * | K101680 | Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesSummary page 4…40 also includes a touch-less IR thermometry option that the 247 does not have. For this added temperature option the Spot Vital Signs LXi by Welch-Allyn Inc. [510k # K101680] is used as a predicate device. (4) Description The CT40 (Model 260) is designed to non-invasively measure systolic and… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192092 | Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 | 2020 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K192092 (Seca GmbH & Co. KG, 2020) has gone furthest, with 0 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. 2016, this device’s year, is highlighted.
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 CT40 (Model 260) is a non-invasive oscillometric spot check vital signs device. The CT40 is capable of measuring and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO2) and body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it is necessary to take one or more vital signs measurements on a patient. The CT40 is only for measurement, recording, and display. It makes no specific diagnoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160439: SunTech CT40 Spot-check Vital Signs Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160439
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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