# K212168: A&D Medical UM-212BLE Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: A&D Company, Ltd.
- Decided: Oct 6, 2022 after 451 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 K982481 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173191: A&D Medical Blood Pressure Monitors, A&D Company, Ltd. (2019) Summary page 4.
- K043217: A&D Medical UA-767PBT Digital Blood Pressure Monitor, A&D Engineering, Inc. (2005) Summary page 4.

## Indications for use
UM-212BLE blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of children and adults who are three (3) years and older in clinics and hospitals. The arm size is from 12 cm (4.7 inches) to 50 cm (19.7 inches). It can detect irregular heartbeats and display a symbol on its display and transmit the measurement by Bluetooth to other devices, such as PC, mobile phones, and gateways.

Source page: https://510kreport.com/device/K212168
Methodology: https://510kreport.com/methodology