# K150430: Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fudakang Industrial Co., Ltd.
- Decided: Apr 17, 2015 after 57 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: 9 generations back to K001670 (2000). 20 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140067: Qardioarm, Qardio, Inc. (2014) Summary page 4.
- K070826: KD-795 Wrist Measurement Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 4.

## Most influential descendants
- K171833: Digital Blood Pressure Monitor-Wrist Style (2018), 4 descendants of its own
- K220651: Wrist Type Blood Pressure Monitor (2022), 2 descendants of its own
- K230409: Wrist Type Blood Pressure Monitor (W05,W1101L) (2023), 1 descendant of its own
- K253570: Blood Pressure Monitor (W06LT) (2026), 0 descendants of its own
- K190982: Automatic Digital Blood Pressure Monitor (2020), 0 descendants of its own

## Indications for use
Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are non-invasive blood measurement system intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments. The Fudakang BT series Blood Pressure Monitors are of Bluetooth transmission function, which enable user to transfer the measurement record from the device to a mobile phone or PC through Bluetooth. Fudakang Arm Blood Pressure Monitor and Wrist Blood Pressure Monitor are not intended to be diagnostic device.

Source page: https://510kreport.com/device/K150430
Methodology: https://510kreport.com/methodology