# K113653: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 6, 2012 after 56 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). 207 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 209 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 1.
- K102835: Vital Signs Monitor, Edan Instruments, Inc. (2010) Summary page 1.
- K083821: Vital Signs Monitor, Edan Instruments, Inc. (2009) Summary page 1.

## Most influential descendants
- K123048: Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A Pro (2013), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1154-2026: 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
The monitor monitors parameters such as ECG (3-lead or 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02. The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility. 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.

Source page: https://510kreport.com/device/K113653
Methodology: https://510kreport.com/methodology