# K120144: Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 14, 2012 after 27 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K102835 (2010). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102835: Vital Signs Monitor, Edan Instruments, Inc. (2010) Summary page 1.
- K111637: Infrared Ear Thermometer, Radiant Innovation, Inc. (2011) Summary page 1.

## Most influential descendants
- K131818: Vital Signs Monitor (2013), 1 descendant of its own
- K180380: vital signs monitor (2018), 0 descendants of its own

## Indications for use
The Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO 2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature). The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves. 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

Source page: https://510kreport.com/device/K120144
Methodology: https://510kreport.com/methodology