# K040528: Amluck YA Horng PC Compatible Wrist Blood Pressure Monitor, Model AK-4000T

- Pathway: 510(k) (Traditional)
- Applicant: Ya Horng Electronic Co., Ltd.
- Decided: Apr 15, 2004 after 45 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.
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)
- K012796: Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000, Amluck, Inc. (2002) Summary page 1.

## Indications for use
The YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, Model AK-4000T, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse 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". * Note. Data Transmission: Connection to PC using RS232 cable.

Source page: https://510kreport.com/device/K040528
Methodology: https://510kreport.com/methodology