# K200437: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Jamr Technology Co., Ltd.
- Decided: Jun 25, 2020 after 122 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: 11 generations back to K850316 (1985). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190507: Full Automatic (NIBP) Blood Pressure Monitor, Health & Life Co., Ltd. (2019) Summary page 4.

## Indications for use
The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being’s upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7” — 15.7”). Not suitable for neonatal and infants.

Source page: https://510kreport.com/device/K200437
Methodology: https://510kreport.com/methodology