# K042138: Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311

- Pathway: 510(k) (Special)
- Applicant: Sein Electronics Co., Ltd.
- Decided: Aug 24, 2004 after 15 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.
3 later devices descend from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K052108: Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 (2005), 2 descendants of its own
- K080853: Duo-Care Blood Glucose and Blood Pressure Monitor System (2009), 0 descendants of its own
- K080636: Duo-Max Blood Pressure & Glucose Monitor HMF-100 (2009), 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/K042138
Methodology: https://510kreport.com/methodology