# K132918: Sense-4BABY System

- Pathway: 510(k) (Traditional)
- Applicant: Sense4baby, Inc.
- Decided: Nov 22, 2013 after 66 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: 2 generations back to K900480 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954351: Series 50XM, Hewlett-Packard GmbH (1996) Summary page 1.

## Most influential descendants
- K222327: Bloomlife MFM-Pro (2023), 0 descendants of its own

## Indications for use
The Sense4Baby System Model B+ is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. It is to be used by health care professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician.

Source page: https://510kreport.com/device/K132918
Methodology: https://510kreport.com/methodology