# K173191: A&D Medical Blood Pressure Monitors

- Pathway: 510(k) (Traditional)
- Applicant: A&D Company, Ltd.
- Decided: Mar 21, 2019 after 535 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 K982481 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061456: A & D Medical UM-101 Digital Blood Pressure Monitor, A&D Engineering, Inc. (2006) Summary page 4.
- K111686: A & D Medical UA-1000 Family Dagital Blood Pressure Monitors, A&D Company, Ltd. (2011) Summary page 4.

## Most influential descendants
- K212168: A&D Medical UM-212BLE Blood Pressure Monitor (2022), 0 descendants of its own

## Indications for use
UM-211 blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of adults who are twelve (12) years and older in the clinics and hospitals. The arm size is from 16 cm (6.3 inches) to 50 cm (19.7 inches). UM-211 can measure blood pressure in auscultatory (device class DXQ) and oscillometric (device class DXN) methods. It can detect irregular heartbeats and display a symbol on its display.

Source page: https://510kreport.com/device/K173191
Methodology: https://510kreport.com/methodology