# K093824: Full Automatic (Nibp) Blood Pressure Monitor, Model HL158BT

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Feb 16, 2010 after 64 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.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130564: Full Automatic (Nibp) Blood Pressure Monitor (2013), 6 descendants of its own
- K160557: Full Automatic (NIBP) Blood Pressure Monitor (2016), 3 descendants of its own
- K151281: AGE Automatic Wrist Blood Pressure Monitor (2015), 3 descendants of its own
- K193628: AGE Automatic Wrist Blood Pressure Monitor (2020), 2 descendants of its own
- K162338: Full Automatic (NIBP) Blood Pressure Monitor (2016), 2 descendants of its own

Source page: https://510kreport.com/device/K093824
Methodology: https://510kreport.com/methodology