# K042014: Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400

- Pathway: 510(k) (Special)
- Applicant: Sein Electronics Co., Ltd.
- Decided: Aug 6, 2004 after 10 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: 2 generations back to K003282 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032927: Full Auto Arm Digital Blood Pressure Monitor, Sein Electronics Co., Ltd. (2004) Summary page 1.

## Indications for use
This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement.

Source page: https://510kreport.com/device/K042014
Methodology: https://510kreport.com/methodology