# K120545: HX-461

- Pathway: 510(k) (Traditional)
- Applicant: Seers Technology Co., Ltd.
- Decided: Oct 23, 2012 after 243 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 K982481 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043217: A&D Medical UA-767PBT Digital Blood Pressure Monitor, A&D Engineering, Inc. (2005) Summary page 1.
- (no number) UA-789: named in the summary without a submission number

## Indications for use
HX-461 is intended for used by adults to measure the systolic and diastolic blood pressure and pulse rate and transfer medical device data electronically to the designated health care center through internet website. HX-461 enables user registration for user-specific data management, and provides blood pressure measurement function. It can receive blood pressure, blood glucose and body fat measurement values by connecting with respective measurement instruments supporting Bluetooth connection, or by docking a blood glucose meter on its back. In addition, HX-461 supports wired/wireless communication with a designated person including video communication.. It has three size of cuff for blood pressure measurement. User chooses the cuff depending on their arm circumference. Cuff size Arm Circumference D-cuff Small :18-22cm D-cuff Adult :22-32cm D-cuff Large 32-45cm

Source page: https://510kreport.com/device/K120545
Methodology: https://510kreport.com/methodology