Cleared Traditional

K253021 - ANNE Maternal (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253021 · Sibel Health, Inc. · Obstetrics & Gynecology device
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Feb 2026
Decision
160d
Days
Class 2
Risk

K253021 is an FDA 510(k) clearance for the ANNE Maternal. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Sibel Health, Inc. (Chicago, US). The FDA issued a Cleared decision on February 26, 2026 after a review of 160 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sibel Health, Inc. devices

Submission Details

510(k) Number K253021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2025
Decision Date February 26, 2026
Days to Decision 160 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 160d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 213
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K253021.
Sonicaid Team3
K250777 · Huntleigh Healthcare , Ltd. · Sep 2025
Fetal & Maternal Monitor (F15A, F15A Air)
K241882 · Edan Instruments, Inc. · Aug 2025
Sonicaid Team3
K241368 · Huntleigh Healthcare , Ltd. · Feb 2025
PeriCALM Patterns 3.0
K241009 · Perigen, Inc. · Jan 2025
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
K233440 · Philips Medizin Systeme Boeblingen GmbH · Jul 2024
Novii+ Wireless Patch System
K231964 · Datex-Ohmeda · Dec 2023