# K191673: Upper Arm Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Famidoc Technology Company Limited
- Decided: Nov 27, 2019 after 156 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: 3 generations back to K123882 (2013). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172895: AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819, Ageless Health Industrial Co., Ltd. (2018) Summary page 5.

## Indications for use
FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.

Source page: https://510kreport.com/device/K191673
Methodology: https://510kreport.com/methodology