# K080789: Blood Pressure Monitor, Models BP-102, BP-103, BP-201 and BP-202

- Pathway: 510(k) (Traditional)
- Applicant: Sejoy Electronics & Instruments Co., Ltd.
- Decided: Apr 3, 2008 after 14 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: 3 generations back to K001670 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042418: KD-575 Memory Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2005) Summary page 1.
- K030359: KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2003) Summary page 1.

## Indications for use
Blood pressure monitor model BP series are designed to measure the systolic. diastolic pressure and pulse rate of people by using (? non-invasive technique. which is a well-known technique in the market called ihe "oscillometric method". BP-102 and BP-103 are the arm-type Blood Pressure Monitors. which can measure the systolic, diastolic pressure and pulse rate at upper-arm. and BP-201 and BP-202 are the wrist-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at wrist. and the devices are reusable for clinical and home use.

Source page: https://510kreport.com/device/K080789
Methodology: https://510kreport.com/methodology