# K242842: ANNE View, Central Hub

- Pathway: 510(k) (Traditional)
- Applicant: Sibel Health, Inc.
- Decided: Jan 8, 2025 after 111 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: 12 generations back to K962603 (1997). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202497: Aulisa Multiple Patient Digital Vital Sign Monitoring System, Taiwan Aulisa Medical Devices Technologies, Inc. (2020) Summary page 5.
- K223711: ANNE One, Sibel Health, Inc. (2023) Summary page 5.

## Most influential descendants
- K243837: iBSM (2025), 0 descendants of its own

## Indications for use
The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party, FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the patient's position has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub, for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters. The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K242842
Methodology: https://510kreport.com/methodology