# K092061: Forecare Advanced Sport Wrist Blood Pressure Monitor, Model FP-0217

- Pathway: 510(k) (Special)
- Applicant: Genexel Medical Instrument, Inc.
- Decided: Mar 26, 2010 after 261 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 K012054 (2001). 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)
- K012054: Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312, Sein Electronics Co., Ltd. (2001)

## Indications for use
This device is an over the counter device, and its intended use is to measure systolic and diastolic pressure and pulse rate of adults, using wrist cuff and oscillometric method of measurement.

Source page: https://510kreport.com/device/K092061
Methodology: https://510kreport.com/methodology