# K130564: Full Automatic (Nibp) Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Jun 19, 2013 after 107 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 K002115 (2000). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093824: Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BT, Health & Life Co., Ltd. (2010) Summary page 1.
- K042967: A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512, A&D Engineering, Inc. (2004) Summary page 1.

## Most influential descendants
- K151281: AGE Automatic Wrist Blood Pressure Monitor (2015), 3 descendants of its own
- K193628: AGE Automatic Wrist Blood Pressure Monitor (2020), 2 descendants of its own
- K213503: Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E (2022), 1 descendant of its own
- K181154: Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor (2019), 1 descendant of its own
- K250161: Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (2025), 0 descendants of its own

## Indications for use
HLIS8LA automatically measures human's Systolic, Diastolic blood pressufe and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(13.5 ¢cm to 19.5 cm) and for home use. When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. And this device can let the memory data be transferred to the connected personal computer (PC) via USB cable. Besides, Risk Category Indicator (Six Levels) feature will judge blood ‘pressure results into six levels based on WHO (World Health Organization) classification with corresponding bar segment on the edge of screen.

Source page: https://510kreport.com/device/K130564
Methodology: https://510kreport.com/methodology