# K131818: Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Aug 30, 2013 after 71 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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: 2 generations back to K102835 (2010). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120144: Vital Signs Monitor, Edan Instruments, Inc. (2012) Summary page 1.
- K003313: Filac Fas Temp Electronic Thermometer, The Kendall Company (2001) Summary page 1.

## Most influential descendants
- K180380: vital signs monitor (2018), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1142-2026: 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.
- Oct 24, 2025 · Class II · Z-1153-2026: 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 Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of Sp0 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/K131818
Methodology: https://510kreport.com/methodology