# K170605: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Mar 27, 2018 after 391 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 K052153 (2005). 4 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133383: HEM-7320, Omron Healthcare, Inc. (2014) Summary page 4.

## Most influential descendants
- K200939: Electronic Blood Pressure Monitor (2020), 6 descendants of its own
- K223170: Electronic Blood Pressure Monitor, model: HTD6602US (2023), 1 descendant of its own
- K193456: Arm Blood Pressure Monitor (2020), 1 descendant of its own
- K253124: Upper arm electronic blood pressure monitor (XB-01) (2026), 0 descendants of its own
- K253228: YUWELL® Electronic Blood Pressure Monitor (YE650AR) (2026), 0 descendants of its own

## Indications for use
Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

Source page: https://510kreport.com/device/K170605
Methodology: https://510kreport.com/methodology