# K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

- Pathway: 510(k) (Traditional)
- Applicant: Current Health, Ltd.
- Decided: Mar 27, 2019 after 70 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: 36 generations back to K941811 (1994). 327 ancestors in all.
18 later devices descend from it; 2 cite it directly.
2 of 346 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package, Snap40, Ltd. (2018) Summary page 8.
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library), Vitalconnect, Inc. (2014) Summary page 8.
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set, Draeger Medical Systems, Inc. (2012) Summary page 8.

## Most influential descendants
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own
- K252981: EmbraceMini (2025), 1 descendant of its own

## Indications for use
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients 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 in adults: • 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 and weight in adults. 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/K190073
Methodology: https://510kreport.com/methodology