HGM
- Product code
- HGM
- Device name
- System, Monitoring, Perinatal
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 215 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254036 | 2026-08-10 | Datex Ohmeda, Inc. | Novii+ Wireless Patch System | |
| K253021 | 2026-02-26 | Sibel Health, Inc. | ANNE Maternal | |
| K250777 | 2025-09-19 | Huntleigh Healthcare , Ltd. | Sonicaid Team3 | |
| K241882 | 2025-08-27 | Edan Instruments, Inc. | Fetal & Maternal Monitor (F15A, F15A Air) | FDA |
| K241368 | 2025-02-03 | Huntleigh Healthcare , Ltd. | Sonicaid Team3 | |
| K241009 | 2025-01-10 | Perigen, Inc. | PeriCALM Patterns 3.0 | |
| K233440 | 2024-07-02 | Philips Medizin Systeme Boeblingen Gmb… | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalo… | |
| K231964 | 2023-12-08 | Datex Ohmeda | Novii+ Wireless Patch System | FDA |
Official FDA classification page: HGM
Classification and pathway per current FDA publications. Data from openFDA (CC0).