# K160981: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 22, 2016 after 259 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 31 generations back to K941811 (1994). 227 ancestors in all.
8 later devices descend from it; 2 cite it directly.
1 of 236 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120173: Patient Monitor, Edan Instruments, Inc. (2012) Summary page 5.
- K092449: Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 5.
- K131971: IM60/IM70 Patient Monitor, Edan Instruments, Inc. (2014) Summary page 5.

## Most influential descendants
- K192514: Patient Monitor (2020), 6 descendants of its own
- K202336: Patient Monitor (2021), 3 descendants of its own
- K232962: Patient Monitor (iX10, iX12, iX15) (2024), 2 descendants of its own
- K220308: Patient Monitor: RespArray (2022), 1 descendant of its own
- K252250: Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (2026), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1146-2026: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

## Indications for use
The monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG). BIS is intended for use on adult and pediatric patients. ICG monitoring is intended for use on adults only. The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are additionally intended for use during patient transport inside hospitals. The monitors are not intended for MRI environments.

Source page: https://510kreport.com/device/K160981
Methodology: https://510kreport.com/methodology