# K110922: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jul 20, 2011 after 110 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: 14 generations back to K941811 (1994). 151 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 153 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053193: PM-8000 Express Patient Monitor, Model PM-8000 Express, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.
- K083821: Vital Signs Monitor, Edan Instruments, Inc. (2009) Summary page 2.
- K032857: Press-Mate BX-10 Vital Sign Monitor, Colin Medical Instruments Corp. (2004) Summary page 2.
- K073280: Beneview T Series Patient Monitors, Models T8, T6 and T5, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K120631: Patient Monitor (2012), 0 descendants of its own

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

## Indications for use
M80: The monitor monitors parameters such as EGG (3-lead, 5-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. M50: The monitor monitors parameters such as EGG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, 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/K110922
Methodology: https://510kreport.com/methodology