# K240251: ANNE Chest

- Pathway: 510(k) (Traditional)
- Applicant: Sibel Health, Inc.
- Decided: Jun 3, 2024 after 125 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K962603 (1997). 112 ancestors in all.
No later device cites it as a predicate yet.
2 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223711: ANNE One, Sibel Health, Inc. (2023) Summary page 4.
- K230626: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™, Ge Medical Systems Information Technologies, Inc. (2023) Summary page 4.

## Indications for use
The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K240251
Methodology: https://510kreport.com/methodology