# K233418: Biofourmis Everion+ (G2)

- Pathway: 510(k) (Traditional)
- Applicant: Biofourmis Singapore Pte., Ltd.
- Decided: May 9, 2024 after 212 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). 360 ancestors in all.
No later device cites it as a predicate yet.
2 of 361 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213863: Everion+ System, Biofourmis Singapore Pte., Ltd. (2023) Summary page 5.
- K210133: Current Health Monitoring System Gen 2 (G2), Current Health (2021) Summary page 5.

## Indications for use
Biofourmis Everion+ (G2) provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest: * Pulse rate * Respiration rate * Movement » Skin temperature Biofourmis Everion+ (G2) also provides Blood oxygen saturation (SpO2) as a vital for continuous data collection in adults, 18 years of age or older, when at rest. Biofourmis Everion+ (G2) is intended for use in a hospital or home environment to support monitoring of wearers under the care of a trained healthcare professional. Biofourmis Everion+ (G2) 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/K233418
Methodology: https://510kreport.com/methodology