# K012054: Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312

- Pathway: 510(k) (Traditional)
- Applicant: Sein Electronics Co., Ltd.
- Decided: Aug 8, 2001 after 37 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042138: Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311 (2004), 3 descendants of its own
- K052108: Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 (2005), 2 descendants of its own
- K092061: Forecare Advanced Sport Wrist Blood Pressure Monitor, Model FP-0217 (2010), 0 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
To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.

Source page: https://510kreport.com/device/K012054
Methodology: https://510kreport.com/methodology