# K123882: Age Automatic Upper Arm Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ageless Health Industrial
- Decided: Aug 14, 2013 after 240 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K110281: Arm Automatic Blood Pressure Meter. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K153552: AGE Automatic Upper Arm Blood Pressure Monitor (2016), 8 descendants of its own
- 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
- K181154: Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor (2019), 1 descendant 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 limited to 24-34 cm.

Source page: https://510kreport.com/device/K123882
Methodology: https://510kreport.com/methodology