# K112270: Accumed Wrist Automatic Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Accumed Healthcare (Shanghai), Inc.
- Decided: Nov 22, 2011 after 106 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: 1 generation back to K100055 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100055: Blood Pressure Meter, Model CH-609, Citizen Systems Japan Co., Ltd. (2010) Summary page 1.

## Indications for use
The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701 is a non-invasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home. The device has an irregular heartbeat (IHB) indicator. The device detects the appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

Source page: https://510kreport.com/device/K112270
Methodology: https://510kreport.com/methodology