# K093739: Blood Pressure Monitor/ Models

- Pathway: 510(k) (Special)
- Applicant: Ningbo Diaier Electronic Co., Ltd.
- Decided: May 7, 2010 after 154 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: 6 generations back to K903134 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091553: Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm Type, Ningbo Diaier Electronic Co., Ltd. (2009) Summary page 2.

## Indications for use
'WAlIOOANA200AIVA300ANB10OONVB200NVD1 00ANEIOOIWF1l00 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 professio nal physician)" "uAAIOO0/AA200/AJBIOO/AC1 00/AD1 00 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from pupper 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 LCID panel, kept in the memory for home care use( without the involvement of professional physician)"

Source page: https://510kreport.com/device/K093739
Methodology: https://510kreport.com/methodology