# K152552: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Apr 29, 2016 after 234 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). 231 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 234 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800, Philips Medizin Systeme Boblingen GmbH (2010) Summary page 4.
- K131971: IM60/IM70 Patient Monitor, Edan Instruments, Inc. (2014) Summary page 4.

## Most influential descendants
- K173042: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (2018), 1 descendant of its own
- K241882: Fetal & Maternal Monitor (F15A, F15A Air) (2025), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1147-2026: 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
iM20 Patient Monitor (hereinafter called monitor) is 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), and invasive blood pressure (IBP), and carbon dioxide (CO2). The arrhythmia detection and ST Segment analysis are intended for adult only. The monitor is additionally intended for use during patient transport inside and outside of the hospital environment. The monitor is not intended for airplane, helicopter transport, home use and MRI environments.

Source page: https://510kreport.com/device/K152552
Methodology: https://510kreport.com/methodology