# K221879: Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

- Pathway: 510(k) (Traditional)
- Applicant: Caf Medical Solutions, Inc.
- Decided: Aug 10, 2022 after 43 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: 31 generations back to K941811 (1994). 225 ancestors in all.
No later device cites it as a predicate yet.
1 of 226 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 5.
- K131971: IM60/IM70 Patient Monitor, Edan Instruments, Inc. (2014) Summary page 5.

## Indications for use
The monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments. The LM-8 monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP). The LM-10 monitor monitors parameters such as ECG (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 (C.O.), Temperature (dual-TEMP) and Expired CO2. The LM-12 monitor monitors parameters such as ECG (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 (C.0O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AQG). The LM-15 monitor monitors parameters such as ECG (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 (C.0O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AQG). The arrhythmia detection and ST Segment analysis are intended for adult and pediatric patients. The monitors are not intended for MRI environments.

Source page: https://510kreport.com/device/K221879
Methodology: https://510kreport.com/methodology