# K113239: Full Automatic (Nibp) Blood Pressure Monitor (Model HL168KF)

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Mar 16, 2012 after 135 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: 6 generations back to K850316 (1985). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092163: Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KB, Health & Life Co., Ltd. (2009) Summary page 1.
- K043217: A&D Medical UA-767PBT Digital Blood Pressure Monitor, A&D Engineering, Inc. (2005) Summary page 1.

## Indications for use
HL168KF 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 use by people over the age of 18 with wrist circumference ranging from approx. 5.3 to 7.7 inches(1 3.5 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. Besides, HL168KF features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.

Source page: https://510kreport.com/device/K113239
Methodology: https://510kreport.com/methodology