# K222327: Bloomlife MFM-Pro

- Pathway: 510(k) (Traditional)
- Applicant: Bloom Technologies NV
- Decided: Feb 13, 2023 after 195 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K900480 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132918: Sense-4BABY System, Sense4baby, Inc. (2013) Summary page 4.

## Indications for use
Bloomlife MFM-Pro is indicated for monitoring of maternal heart rate (MHR) and fetal heart rate (FHR) during the antepartum period for singleton pregnancies 32 weeks gestation or later. It is to be used by healthcare professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician. Bloomlife MFM-Pro is not intended for use in critical care situations or in laboring patients or those patients hospitalized for or suspected to have preterm labor. Bloomlife MFM-Pro is not intended to be used for antepartum monitoring (e.g., non-stress testing).

Source page: https://510kreport.com/device/K222327
Methodology: https://510kreport.com/methodology