# K092161: Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Sep 30, 2009 after 76 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: 5 generations back to K850316 (1985). 11 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060835: HL888SF, Health & Life Co., Ltd. (2006) Summary page 1.
- K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3, Omron Healthcare, Inc. (2006) Summary page 1.
- K080177: Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV, Nihon Seimitsu Sokki Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K093831: Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT (2010), 12 descendants of its own
- K131121: Full Automatic (Nibp) Blood Pressure Monitor (2013), 9 descendants of its own
- K113238: Full Automatic (Nibp) Blood Pressue Monitor (2012), 9 descendants of its own
- K142968: Full Automatic (NIBP) Blood Pressure Monitor (2014), 8 descendants of its own
- K160145: Full Automatic (NIBP) Blood Pressure Monitor (2016), 3 descendants of its own

## Indications for use
HL868BF Measures automatically human's Systolic, Diastolic blood pressure 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 upper arm. The intended use of this over-the-counter device, is for over the age of 18 with arm circumference ranging from 9 inches to 17 inches (23 cm to 43 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.

Source page: https://510kreport.com/device/K092161
Methodology: https://510kreport.com/methodology