ANNE Maternal

FDA 510(k) K253021 · Sibel Health, Inc.

Substantially Equivalent

510(k) numberK253021

Submission

Device name
ANNE Maternal
Applicant
Sibel Health, Inc.
Chicago, IL, US
Received
September 19, 2025
Decision date
February 26, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HGM – System, Monitoring, Perinatal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2740
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HGM

510(k)DeviceApplicantDecision
K254036Novii+ Wireless Patch SystemHGM · Traditional Datex Ohmeda, Inc.08/10/2026SE
K250777Sonicaid Team3HGM · Traditional Huntleigh Healthcare , Ltd.09/19/2025SE
K241882Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional Edan Instruments, Inc.08/27/2025SE
K241368Sonicaid Team3HGM · Traditional Huntleigh Healthcare , Ltd.02/03/2025SE
K241009PeriCALM Patterns 3.0HGM · Traditional Perigen, Inc.01/10/2025SE
K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional Philips Medizin Systeme Boeblingen GmbH07/02/2024SE
K231964Novii+ Wireless Patch SystemHGM · Traditional Datex Ohmeda12/08/2023SE
K222327Bloomlife MFM-ProHGM · Traditional Bloom Technologies NV02/13/2023SE
K220732Mural Perinatal SurveillanceHGM · Traditional Ge Medical Systems Information Technologies, Inc.06/23/2022SE
K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHGM · Traditional Huntleigh Healthcare Limited06/24/2020SE

More from Huntleigh Healthcare Limited

510(k)DeviceDecision
K242842ANNE View, Central HubMSX · Traditional 01/08/2025SE
K240251ANNE ChestDRG · Traditional 06/03/2024SE
K240305ANNE LimbDQA · Traditional 05/28/2024SE
K223711ANNE OneDRG · Traditional 08/10/2023SE

Questions and answers

When was ANNE Maternal cleared by the FDA?

ANNE Maternal (K253021) received a 510(k) decision of Substantially Equivalent on February 26, 2026, 160 days after the submission was received.

What is the product code of K253021?

The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.