# K012310: Modification to:HL168D Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Health & Life Co., Ltd.
- Decided: Aug 22, 2001 after 30 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.
9 later devices descend from it; 1 cites it directly.
0 of 10 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
- K030230: Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor) (2003), 8 descendants of its own
- K110299: Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series (2011), 7 descendants of its own
- K120673: Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series (2013), 6 descendants of its own
- K133618: Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series (2014), 5 descendants of its own
- K142088: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (2014), 2 descendants of its own

## Indications for use
Measures automatically human’s Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel. The intended for use of this over-the-counter device is for age 16 and above.

Source page: https://510kreport.com/device/K012310
Methodology: https://510kreport.com/methodology