# K131971: IM60/IM70 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Mar 20, 2014 after 265 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: 30 generations back to K941811 (1994). 224 ancestors in all.
14 later devices descend from it; 4 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)
- K113623: Patient Monitor, Edan Instruments, Inc. (2012) 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
- K152552: Patient Monitor (2016), 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
iM6O: The iM6O monitor monitors parameters such as EGG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO 2 ), Invasive or noninvasive blood pressure (2/4 channels ISP NIBP), Cardiac Output (00), Temperatre (dual-TEMP) and Expired C02. 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. iM7O: The iM7O monitor monitors parameters such as EGG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO 2 ), Invasive or noninvasive blood pressure (214 channels ISP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired 002 and Anesthetic gas (AG). The monitor is equipped wit 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/K131971
Methodology: https://510kreport.com/methodology