# K202336: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jan 23, 2021 after 159 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: 33 generations back to K941811 (1994). 229 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 233 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192514: Patient Monitor, Edan Instruments, Inc. (2020) Summary page 5.

## Most influential descendants
- K232962: Patient Monitor (iX10, iX12, iX15) (2024), 2 descendants 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
- K250179: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (2025), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1145-2026: 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, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics. 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 (SpO 2 ), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (C02), cardiac output (C.O.), and Anaesthesia gas(AG). The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are not intended for MRI environments.

Source page: https://510kreport.com/device/K202336
Methodology: https://510kreport.com/methodology