# K012796: Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000

- Pathway: 510(k) (Traditional)
- Applicant: Amluck, Inc.
- Decided: Mar 14, 2002 after 205 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: 1 generation back to K001182 (2000). 1 ancestor in all.
28 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001182: Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1, Microlife Corp. (2000) Summary page 1.

## Most influential descendants
- K051862: PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R; Automatic Digital Wrist Blood Press. Monitor. (2005), 25 descendants of its own
- 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

## Indications for use
The Amluck automatic digital wrist blood pressure monitor, Model AK-3000 / AK-4000, 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”.

Source page: https://510kreport.com/device/K012796
Methodology: https://510kreport.com/methodology