# K212312: RA-T59 Wrist blood pressure monitor

- Pathway: 510(k) (Traditional)
- Applicant: Lotusnine Medical Limited
- Decided: Jan 27, 2022 after 188 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: 2 generations back to K042505 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131742: HEM-6131, Omron Healthcare, Inc. (2013) Summary page 4.

## Indications for use
The device is a digital monitor for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 inches to 7 1/4 inches (12.8 cm to 18.5 cm).

Source page: https://510kreport.com/device/K212312
Methodology: https://510kreport.com/methodology