# K193628: AGE Automatic Wrist 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002115 (2000). 7 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K151281: AGE Automatic Wrist Blood Pressure Monitor, Dongguan Ageless Health Industrial Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K213503: Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E (2022), 1 descendant of its own
- K250161: Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (2025), 0 descendants of its own

## Indications for use
Automatic Wrist 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 wrist. The cuff circumference is limited to 13.5 cm~19.5 cm.

Source page: https://510kreport.com/device/K193628
Methodology: https://510kreport.com/methodology