# K070209: FB-100U Series Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fego Precision Industrial Co;, Ltd.
- Decided: Aug 8, 2007 after 198 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
Longest line of descent: 1 generation back to K021225 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021225: Rossmax Automatic Blood Pressure Monitor, Model Cardiocare 1000I, Rossmax International, Ltd. (2002) Summary page 1.

## Indications for use
FB-10OU Series Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use by people over 15 years old in home use.

Source page: https://510kreport.com/device/K070209
Methodology: https://510kreport.com/methodology