# K232495: Sempulse Halo Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sempulse Corporation
- Decided: May 16, 2024 after 273 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Halo vital signs monitor is a prescription device intended to be used as an adult patient monitor. It is indicated as a single- or multi-parameter vital signs monitor for SpO2 – pulse oximetry, pulse rate, respiratory rate, core body temperature, and skin temperature for spot-check measurements and continuous monitoring from the back of the cavum concha and the neck. The Halo monitor may be used in hospitals, healthcare facilities, emergency medical applications, medical transport, home healthcare settings, and other healthcare applications to include medical military settings in the field. The monitor is intended to be used in trauma scenarios, triage, motion, low perfusion, general monitoring, remote monitoring, and telemedicine settings. It is reusable, transportable, and for use in all types of ambulances. The Halo monitor uses wired or wireless communications to transmit vital signs data to a handheld or personal computer. The monitor is intended to be used by trained healthcare providers who are trained to interpret the vital signs readings and make appropriate medical interventions or patients who are under the direct care and guidance of a medical professional or doctor. Alarms can be set with user-defined thresholds.

Source page: https://510kreport.com/device/K232495
Methodology: https://510kreport.com/methodology