# K071523: Full Auto Wrist Digital Blood Pressure Monitor, Models BP1600, BP1650, BP1700 and BP1750

- Pathway: 510(k) (Special)
- Applicant: Genexel-Sein, Inc.
- Decided: Jun 26, 2007 after 22 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) Summary page 1.

## Indications for use
To measure systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.

Source page: https://510kreport.com/device/K071523
Methodology: https://510kreport.com/methodology