# K032927: Full Auto Arm Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sein Electronics Co., Ltd.
- Decided: May 7, 2004 after 228 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 K003282 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003282: Full Auto Blood Pressure Monitor, Model SE-7700H, Sein Electronics Co., Ltd. (2000) Summary page 2.

## Most influential descendants
- K042014: Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400 (2004), 0 descendants of its own

## 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/K032927
Methodology: https://510kreport.com/methodology