# K172895: AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819

- Pathway: 510(k) (Traditional)
- Applicant: Ageless Health Industrial Co., Ltd.
- Decided: Jun 18, 2018 after 269 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: 2 generations back to K123882 (2013). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153552: AGE Automatic Upper Arm Blood Pressure Monitor, Ageless Health Industrial Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K193627: Automatic Upper Arm Blood Pressure Monitor (2020), 3 descendants of its own
- K222926: Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 (2023), 1 descendant of its own
- K250231: Automatic Upper Arm Blood Pressure Monitor  (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) (2025), 0 descendants of its own
- K241590: Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (2025), 0 descendants of its own
- K193624: Automatic Upper Arm Blood Pressure Monitor (2020), 0 descendants of its own

## Indications for use
AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.

Source page: https://510kreport.com/device/K172895
Methodology: https://510kreport.com/methodology