# K183687: LifeWindow LW8 Lite

- Pathway: 510(k) (Traditional)
- Applicant: Digicare Biomedical Technology, Inc.
- Decided: Sep 25, 2019 after 271 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: 14 generations back to K962603 (1997). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 78 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131898: A Series and Q Series Patient Monitors, Guangdong Biolight Meditech Co., Ltd. (2014) Summary page 5.
- K122290: Envitec Mysign O Oxygen Measuring Device, Envitec-Wismar GmbH (2013) Summary page 5.
- K110028: Masimo Radical Y Pulse CO-Oximeter, Masimo Corporation (2011) Summary page 5.

## Most influential descendants
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own

## Indications for use
The LifeWindow™ LW8 Lite is a multi-parameter physiological patient monitor indicated for continuous measurement of the following parameters: • ECG waveforms from 3 or 5 lead measurements • Heart Rate (from ECG) • Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value • End-tidal CO2 concentration (EtCO2) – Mainstream or Sidestream • Inspired CO2 concentration (insCO2) – Mainstream or Sidestream • Fractional Inspired Oxygen (FiO2) • Acoustic Respiration Rate (RRa) • Respiration Rate (from bioimpedance or EtCO2 measurement, or RRa) • Two Temperature channels • Two Invasive Pressure channels (IP1, IP2) • Pulse Rate in BPM (from Pulse CO-Oximetry and/or NIBP) • Pulse CO-Oximetry and pulse rate – the LifeWindow LW8 Lite Pulse CO-Oximeter functions and accessories incorporating Masimo technology are indicated for the continuous noninvasive monitoring of the following parameters during both no motion and motion conditions, and for patients who are well or poorly perfused: o Functional oxygen saturation of arterial hemoglobin (SpO2) o Carboxyhemoglobin saturation (SpCO) o Methemoglobin saturation (SpMet) o Total hemoglobin concentration (SpHb) The defined patient population is adult through neonatal patients with appropriate accessories. The monitor displays a range of physiological waveforms and indices and provides alarms. The LifeWindow™ LW8 Lite multi-parameter patient monitor may be used in hospitals, hospital-type facilities, surgery centers, and emergency facilities. For professional use only. It is not intended for helicopter transport, hospital ambulance, or home use.

Source page: https://510kreport.com/device/K183687
Methodology: https://510kreport.com/methodology