# K221616: Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

- Pathway: 510(k) (Traditional)
- Applicant: Caf Medical Solutions, Inc.
- Decided: Aug 1, 2022 after 59 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: 32 generations back to K941811 (1994). 228 ancestors in all.
No later device cites it as a predicate yet.
1 of 229 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160981: Patient Monitor, Edan Instruments, Inc. (2016) Summary page 4.

## 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, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG). BIS is intended for use on adult and pediatric patients. ICG monitoring is intended for use on adults only. The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are additionally intended for use during patient transport inside hospitals. The monitors are not intended for MRI environments.

Source page: https://510kreport.com/device/K221616
Methodology: https://510kreport.com/methodology