# K190927: Oscillometric Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Rudolf Riester GmbH
- Decided: Jun 24, 2019 after 76 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: 8 generations back to K903134 (1991). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101275: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib (TWIN200 Afs)., Microlife Intellectual Property GmbH (2010) Summary page 6.

## Indications for use
This oscillometric blood pressure monitor is intended to measure the systolic and diastolic blood pressure, pulse rate and mean arterial pressure (MAP) in people aged 3 years or older. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.

Source page: https://510kreport.com/device/K190927
Methodology: https://510kreport.com/methodology