# K062033: BP 101 Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Kingyield Hongkong Limited
- Decided: Mar 23, 2007 after 248 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 K001670 (2000). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001670: Automatic Blood Pressure Monitor with Intellisense, Model Hem-757, Omron Healthcare, Inc. (2000) Summary page 1.

## Most influential descendants
- K080206: Modification to Femostop Femoral Compression System (2008), 3 descendants of its own
- K192413: SiteSeal Femoral Compression Device (2020), 0 descendants of its own
- K120204: Reprocessed Femoral Compression Device (2012), 0 descendants of its own
- K110193: Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II Plus Arch, Bilateral Adapter; F (2011), 0 descendants of its own

## Indications for use
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate. The device is intended for use in only adult population, not applied to the other populations such as neonatal baby. It can not be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

Source page: https://510kreport.com/device/K062033
Methodology: https://510kreport.com/methodology