# K990807: HL148 & HL168

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Dec 3, 1999 after 267 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K032308: Blood Pressure Monitor, Model M100 (2003), 0 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/K990807
Methodology: https://510kreport.com/methodology