# K232962: Patient Monitor (iX10, iX12, iX15)

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Apr 19, 2024 after 211 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: 34 generations back to K941811 (1994). 230 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 233 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202336: Patient Monitor, Edan Instruments, Inc. (2021) Summary page 6.

## Most influential descendants
- K252250: Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (2026), 0 descendants of its own
- K250179: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (2025), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1149-2026: 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
The iX series Patient Monitors including iX10, iX12, iX15 are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), and Anaesthesia gas (AG). The arrhythmia detection and ST Segment analysis are intended for adult patients. The NIBP monitoring supports iCUFS algorithm and iFAST algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatric patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women. The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients. The monitors are not intended for MRI environments. The cardiac output (C.O.) is only intended for adult patients.

Source page: https://510kreport.com/device/K232962
Methodology: https://510kreport.com/methodology