# K211305: ANNE One

- Pathway: 510(k) (Traditional)
- Applicant: Sibel, Inc.
- Decided: Sep 14, 2021 after 138 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: 10 generations back to K962603 (1997). 27 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172329: Patient Status Engine, Isansys Lifecare, Ltd. (2018) Summary page 4.

## Most influential descendants
- K223711: ANNE One (2023), 4 descendants of its own
- 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 vital signs and physiological data monitoring platform indicated for the measurement of heart rate, respiratory rate, step count, fall count, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. The device is not intended to monitor or measure respiratory rate or heart rate on ambulatory patients.

Source page: https://510kreport.com/device/K211305
Methodology: https://510kreport.com/methodology