# K022926: Genteel Wrist Digital Blood Pressure Monitor, Model BP-100

- Pathway: 510(k) (Traditional)
- Applicant: Genteel Technology Co., Ltd.
- Decided: Jun 6, 2003 after 306 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OMRON HEM-608 Wrist Blood Pressure Monitor: named in the summary without a submission number

## Indications for use
The device is noninvasive and provide Systolic, Diastolic blood pressure and pulse rate(heart rate) mesurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD Panel. The Device is indicated for use by people over 15 age old in home use.

Source page: https://510kreport.com/device/K022926
Methodology: https://510kreport.com/methodology