# K050249: HL168JP

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Mar 30, 2005 after 55 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070473: Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX (2007), 4 descendants of its own
- K091553: Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm Type (2009), 2 descendants of its own
- K123839: WA Series: WA100; WA200; WD100; WE100, WF100; WB200 (2013), 0 descendants of its own
- K093739: Blood Pressure Monitor/ Models (2010), 0 descendants of its own
- K090027: Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107 (2009), 0 descendants of its own

## Indications for use
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read cut in one LCD PANEL. One or two readings will not provide a true indication of your normal blood pressure. It is very important to take regular, daily measurements and to keep accurate records at home. (Try to measure your blood pressure at the same time each day for consistency). In partnership with your doctor, an accurate record of your blood pressure over a period of time can be a valuable aid in diagnosing and preventing potential health problems.

Source page: https://510kreport.com/device/K050249
Methodology: https://510kreport.com/methodology