# K192092: Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535

- Pathway: 510(k) (Traditional)
- Applicant: Seca GmbH & Co. KG
- Decided: Jan 23, 2020 after 171 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: 5 generations back to K951193 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160439: SunTech CT40 Spot-check Vital Signs Device, Suntech Medical (2016) Summary page 5.

## Indications for use
The medical Vital Signs Analyzer seca mVSA 535 is a Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body temperature) and PR (pulse rate). The vital signs monitor model seca mVSA 535 is mainly used in inpatient facilities (hospitals, medical practices and care facilities) in accordance with national regulations and is intended to be used on adult and pediatric individuals (3 years of age or older). The seca mVSA 535 can be used in conjunction with an optional PC software accessory for data management, calculations and display of information. If used in conjunction with seca medical weight and height measurement devices the seca mVSA 535 can receive and display weight and height values.

Source page: https://510kreport.com/device/K192092
Methodology: https://510kreport.com/methodology