# K160439: SunTech CT40 Spot-check Vital Signs Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Suntech Medical
- Decided: Jul 6, 2016 after 140 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: 4 generations back to K951193 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070750: 247 BP Device, Suntech Medical, Inc. (2007) Summary page 4.
- K101680: Welch Allyn Spot Vital Signs Lxi Model 45000 Series, Welch Allyn, Inc. (2010) Summary page 4.

## Most influential descendants
- K192092: Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K160439
Methodology: https://510kreport.com/methodology