# K091553: Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm Type

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Diaier Electronic Co., Ltd.
- Decided: Sep 21, 2009 after 117 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 K903134 (1991). 7 ancestors in all.
2 later devices descend from it; 2 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)
- K070473: Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX, Zen Strong Medical Technology Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K123839: WA Series: WA100; WA200; WD100; WE100, WF100; WB200 (2013), 0 descendants of its own
- K093739: Blood Pressure Monitor/ Models (2010), 0 descendants of its own

## Indications for use
WA400 blood pressure monitor measures automatically human being~ systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician) AA300 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory, and then transferred to the other data memory media through USB connection port for home car6 use( without the involvement of professional physician).

Source page: https://510kreport.com/device/K091553
Methodology: https://510kreport.com/methodology