# K153552: AGE Automatic Upper Arm Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ageless Health Industrial Co., Ltd.
- Decided: Jun 1, 2016 after 173 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: 1 generation back to K123882 (2013). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123882: Age Automatic Upper Arm Blood Pressure Monitor, Ageless Health Industrial (2013) Summary page 5.

## Most influential descendants
- K172895: AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 (2018), 6 descendants of its own
- 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

## Indications for use
AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is six sizes.

Source page: https://510kreport.com/device/K153552
Methodology: https://510kreport.com/methodology