# K231506: Current Health System

- Pathway: 510(k) (Special)
- Applicant: Current Health, Ltd.
- Decided: Aug 24, 2023 after 92 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 39 generations back to K941811 (1994). 356 ancestors in all.
No later device cites it as a predicate yet.
2 of 357 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222550: Current Health System, Current Health, Ltd. (2022) Summary page 6.

## Indications for use
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic monitoring of patients aged 14 years old and above in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters: • Pulse rate • Oxygen saturation • Temperature • Movement The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring of: • Respiration rate • Non-invasive blood pressure • Lung function & spirometry • Weight The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

Source page: https://510kreport.com/device/K231506
Methodology: https://510kreport.com/methodology