# K120173: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: May 16, 2012 after 117 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K941811 (1994). 216 ancestors in all.
10 later devices descend from it; 2 cite it directly.
1 of 227 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102825: Blood Pressure Cuff, APK Technology Co., Ltd. (2011) Summary page 2.
- 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.
- K083821: Vital Signs Monitor, Edan Instruments, Inc. (2009) Summary page 2.
- K032363: Zoll M Series Nibp Option, Zoll Medical Corp (2003) Summary page 2.
- K103604: Isa CO2, Isa AX+, Isa or+, Phasein AB (2011) Summary page 2.

## Most influential descendants
- 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
- K220308: Patient Monitor: RespArray (2022), 1 descendant of its own

## Indications for use
This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (ISP), expired CO2, cardiac output (C.O.) and anesthetic gas (AG) of adults, pediatrics and neonates in hospital environments. 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. This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.

Source page: https://510kreport.com/device/K120173
Methodology: https://510kreport.com/methodology