# K112320: Full Automatic (Nibp) Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Sep 30, 2011 after 50 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 K050714 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050714: Full Automatic (Nibp) Blood Pressure Monitor, Models HL168GA, HL168GS, Health & Life Co., Ltd. (2005) Summary page 1.

## Indications for use
HL168JD uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's wrist. All values can be read out in one LCD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3 - 7.7 inch (135 - 195 mm).

Source page: https://510kreport.com/device/K112320
Methodology: https://510kreport.com/methodology