# K132033: BM3/BM3 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Noblitt & Rueland
- Decided: Dec 4, 2013 after 156 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: 13 generations back to K941811 (1994). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082008: Bionet BM3PLUS Patient Monitor, Bionet Co., Ltd. (2008) Summary page 1.
- K103686: STAR 50 N, Larsen & Toubro Limited (2011) Summary page 1.

## Indications for use
The Bionet BM3/BM3 Plus 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: end-tidal CO 2 , 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 device is not intended for use as an apnea monitor, and it is not intended for use during MRI or CT scans.

Source page: https://510kreport.com/device/K132033
Methodology: https://510kreport.com/methodology