# K113623: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 1, 2012 after 58 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K941811 (1994). 223 ancestors in all.
15 later devices descend from it; 2 cite it directly.
1 of 239 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100939: Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 and MP90, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2010) Summary page 2.
- K102825: Blood Pressure Cuff, APK Technology Co., Ltd. (2011) Summary page 2.
- K083821: Vital Signs Monitor, Edan Instruments, Inc. (2009) Summary page 2.
- K032363: Zoll M Series Nibp Option, Zoll Medical Corp (2003) Summary page 2.
- K032857: Press-Mate BX-10 Vital Sign Monitor, Colin Medical Instruments Corp. (2004) Summary page 2.
- K103604: Isa CO2, Isa AX+, Isa or+, Phasein AB (2011) Summary page 2.

## Most influential descendants
- K131971: IM60/IM70 Patient Monitor (2014), 14 descendants of its own
- K160981: Patient Monitor (2016), 8 descendants of its own
- 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

## 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.
- Jun 23, 2016 · Class II · Z-2388-2016: Incorrect CO2 readings with some patient monitors.

## Indications for use
iMSO: The monitor monitors parameters such as EGG (3-lead, S-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (GO), Temperature (dual-TEMP), Expired C02 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. iMSO: The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO 2 ), Invasive or noninvasive blood pressure (dual-IB3P, NIBP), Temperature (dual-TEMP), Expired C02 and Quick Temperature (Quick TEMP. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

Source page: https://510kreport.com/device/K113623
Methodology: https://510kreport.com/methodology