# K223711: ANNE One

- Pathway: 510(k) (Traditional)
- Applicant: Sibel Health, Inc.
- Decided: Aug 10, 2023 after 241 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: 11 generations back to K962603 (1997). 28 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211305: ANNE One, Sibel, Inc. (2021) Summary page 4.

## Most influential descendants
- K242842: ANNE View, Central Hub (2025), 1 descendant of its own
- K243837: iBSM (2025), 0 descendants of its own
- K240251: ANNE Chest (2024), 0 descendants of its own
- K240305: ANNE Limb (2024), 0 descendants of its own

## Indications for use
ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature, and body temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate, SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active. ANNE One continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the patient’s position has not changed from a preset threshold of time. The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K223711
Methodology: https://510kreport.com/methodology