# K092163: Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KB

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Nov 16, 2009 after 123 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060729: Full Automatic (Nibp) Blood Pressure Monitor, Model HL168FV, Health & Life Co., Ltd. (2006) Summary page 1.
- K042505: Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N, Omron Healthcare, Inc. (2005) 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
- K113239: Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF) (2012), 0 descendants of its own

## Recalls of this device
- Sep 17, 2010 · Not classified · Z-2578-2011: When a dialog box is displayed and the dose status is changed to "Dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocent

## Indications for use
HL168KB automatically measures 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 wrist. The intended use of this over-the-counter device is for over the age of 18 with wrist circumference ranging from 135 mm to 195 mm (Approx. 5.3-7.7 inches) 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 storage data be transferred to the connected personal computer (PC) via USB cable.

Source page: https://510kreport.com/device/K092163
Methodology: https://510kreport.com/methodology