# K193627: Automatic Upper Arm Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan E-Test Technology Co., Ltd.
- Decided: Jul 12, 2020 after 199 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 4 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 7 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 6.
- 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 6.

## Most influential descendants
- 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

## Recalls of this device
- Aug 30, 2024 · Class II · Z-0032-2025: It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating
- Aug 30, 2024 · Class II · Z-0034-2025: It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating
- Aug 30, 2024 · Class II · Z-0033-2025: It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating
- Feb 26, 2024 · Class II · Z-1459-2024: The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units

## Indications for use
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 an air cuff buckled around one's arm according to the instruction in the user's guide manual.

Source page: https://510kreport.com/device/K193627
Methodology: https://510kreport.com/methodology