# K051862: PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R; Automatic Digital Wrist Blood Press. Monitor.

- Pathway: 510(k) (Traditional)
- Applicant: Ya Horng Electronic Co., Ltd.
- Decided: Aug 23, 2005 after 46 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 K001182 (2000). 2 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012796: Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000, Amluck, Inc. (2002) Summary page 1.

## Most influential descendants
- K072860: YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital Wrist Blood Pressure Monitor, BP-500,BP-500 (2008), 24 descendants of its own
- K090058: YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB (2009), 23 descendants of its own
- K121025: YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth Transmission (2012), 15 descendants of its own
- K140067: Qardioarm (2014), 8 descendants of its own
- K150430: Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor (2015), 6 descendants of its own

## Indications for use
The YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and bulse rate of an adult individual, over age .18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5". BP-410R, BP-420R: Data Transmission: Connection to PC using RS232 cable. AK-4000TU, BP-410U, BP-420U: Data Transmission: Connection to PC using USB cable

Source page: https://510kreport.com/device/K051862
Methodology: https://510kreport.com/methodology