# K082008: Bionet BM3PLUS Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Bionet Co., Ltd.
- Decided: Dec 11, 2008 after 149 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K021154 (2003). 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)
- K021154: Goldway Patient Monitor, Model # UT4000F, Goldway Us, Inc. (2003) Summary page 1.

## Most influential descendants
- K132033: BM3/BM3 Plus (2013), 0 descendants of its own

## Indications for use
The patient monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities. Physiological data include but are not restricted to: electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits. The patient monitor is not intended for use as an apnea monitor. The patient monitor is not intended for use during MRI or CT scans.

Source page: https://510kreport.com/device/K082008
Methodology: https://510kreport.com/methodology