# K112465: Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instruments, Inc.
- Decided: Sep 14, 2011 after 19 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 2.

## Indications for use
The Vital Signs Monitors models VSM-300 and VSM-300A (hereinafter called monitor) are intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature). The monitors are 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 monitors are 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/K112465
Methodology: https://510kreport.com/methodology