Bloomlife MFM-Pro
FDA 510(k) K222327 · Bloom Technologies NV
510(k) numberK222327
Submission
- Device name
- Bloomlife MFM-Pro
- Applicant
- Bloom Technologies NV
Genk, BE - Received
- August 2, 2022
- Decision date
- February 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K254036 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda, Inc. | 08/10/2026SE |
| K253021 | ANNE MaternalHGM · Traditional | Sibel Health, Inc. | 02/26/2026SE |
| K250777 | Sonicaid Team3HGM · Traditional | Huntleigh Healthcare , Ltd. | 09/19/2025SE |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional | Edan Instruments, Inc. | 08/27/2025SE |
| K241368 | Sonicaid Team3HGM · Traditional | Huntleigh Healthcare , Ltd. | 02/03/2025SE |
| K241009 | PeriCALM Patterns 3.0HGM · Traditional | Perigen, Inc. | 01/10/2025SE |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/02/2024SE |
| K231964 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda | 12/08/2023SE |
| K220732 | Mural Perinatal SurveillanceHGM · Traditional | Ge Medical Systems Information Technologies, Inc. | 06/23/2022SE |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHGM · Traditional | Huntleigh Healthcare Limited | 06/24/2020SE |
Questions and answers
When was Bloomlife MFM-Pro cleared by the FDA?
Bloomlife MFM-Pro (K222327) received a 510(k) decision of Substantially Equivalent on February 13, 2023, 195 days after the submission was received.
What is the product code of K222327?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.