# K240305: ANNE Limb

- Pathway: 510(k) (Traditional)
- Applicant: Sibel Health, Inc.
- Decided: May 28, 2024 after 116 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 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.

## Indications for use
The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use 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/K240305
Methodology: https://510kreport.com/methodology