ANNE Maternal— 510(k) K253021
Substantially EquivalentSibel Health, Inc.
FDA 510(k) clearance K253021 for ANNE Maternal, Substantially Equivalent on 2026-02-26. Applicant: Sibel Health, Inc.. Device class: 2.
Summary
Sibel Health's ANNE Maternal is filed under product code HGM, perinatal monitoring system. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 884.2740. Obstetrics/Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Sibel Health filed from Chicago, Illinois. Review took 160 calendar days (September 19, 2025 to February 26, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Sibel Health, Inc.
- Product code
- Product code HGM
- Device class
- Class 2
- Regulation
- 21 CFR 884.2740
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code HGM
view allMore clearances from Sibel Health, Inc.
view allAdverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.