# K131898: A Series and Q Series Patient Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Feb 18, 2014 after 238 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: 9 generations back to K963644 (1996). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120193: Any View Patient Monitors, Guangdong Biolight Meditech Co., Ltd. (2012) Summary page 3.
- K072286: Bis Eeg Vista Monitor System and Bisx, Aspect Medical Systems, Inc. (2007) Summary page 3.

## Most influential descendants
- K183687: LifeWindow LW8 Lite (2019), 1 descendant of its own
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own

## Indications for use
Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO 2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (C02), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (HIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), and Methemoglobin(SpMet). The arrhythmia detection, ST segment analysis only applied to a single adult patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.

Source page: https://510kreport.com/device/K131898
Methodology: https://510kreport.com/methodology