# K150908: XM-01 Electronic Automatic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sky Innovation Technology ( Shanghai) Limited
- Decided: Dec 16, 2015 after 257 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: 3 generations back to K042505 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123669: Transtek Wrist Blood Pressure Monitor, Zhongshan Transtek Electronics Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K222394: Electronic Sphygmomanometers (2023), 0 descendants of its own

## Indications for use
XM-01 Automatic Electronic Blood Pressure Monitor is a home use digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm. The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K150908
Methodology: https://510kreport.com/methodology