# K213863: Everion+ System

- Pathway: 510(k) (Traditional)
- Applicant: Biofourmis Singapore Pte., Ltd.
- Decided: Feb 23, 2023 after 440 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: 38 generations back to K941811 (1994). 358 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 360 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191272: Wearable Device, Wearable Package, Current Health, Ltd. (2019) Summary page 4.
- K191620: Vitls Platform, Vitls, Inc. (2020) Summary page 4.

## Most influential descendants
- K233418: Biofourmis Everion+ (G2) (2024), 0 descendants of its own

## Indications for use
Everion+ provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest: • Pulse rate • Respiration rate • Movement The data from Everion+ is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.

Source page: https://510kreport.com/device/K213863
Methodology: https://510kreport.com/methodology