# K253021: ANNE Maternal

- Pathway: 510(k) (Traditional)
- Applicant: Sibel Health, Inc.
- Decided: Feb 26, 2026 after 160 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K864318 (1987). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250777: Sonicaid Team3, Huntleigh Healthcare, Ltd. (2025) Summary page 5.

## Indications for use
The ANNE® Maternal system is a perinatal monitoring platform intended for the continuous collection, display, and storage of physiological data and vital signs from compatible medical devices in clinical settings. The system supports data acquisition from sensors, clinician inputted data, and compatible software for maternal and fetal monitoring in singleton pregnancies. Examples of parameters include maternal vital signs (e.g. heart rate, respiratory rate, SpO2, blood pressure, temperature), fetal heart rate, and uterine contractions. The system provides both visual and audio alarms, alerts, and notifications at the bedside via a mobile device or a compatible central monitor. The ANNE® Maternal system is intended for use by qualified healthcare professionals. This device is intended for use by healthcare professionals to support clinical decision-making. All information provided by the system is intended to supplement, not replace, the judgement of medical professionals and is not intended to be the sole source of information for decision-making. The physiological parameters collected by the ANNE® Maternal system is inputted into the integrated electronic Modified Early Obstetric Warning System (MEOWS) tool, which provides information that can signal the need for prompt bedside evaluation by the health care provider. This information is intended as adjunctive information only and is not intended to replace or supersede the review of individual vital signs by qualified healthcare professionals. This information is intended to supplement, and not replace, the judgment of medical professionals and is not intended to be the sole source of information for decision-making.

Source page: https://510kreport.com/device/K253021
Methodology: https://510kreport.com/methodology