# K143114: Sense4Baby System Model B+ (MSA)

- Pathway: 510(k) (Traditional)
- Applicant: Airstrip Technologies, Inc.
- Decided: Mar 10, 2015 after 131 days
- Product code: LQK (Home Uterine Activity Monitor)
- Device class: 2
- Regulation: 21 CFR 884.2730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002548 (2001). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020390: Modification to Fetal Assist, Huntleigh Diagnostics, Ltd. (2002) Summary page 4.

## Most influential descendants
- K210025: INVU by Nuvo (2021), 1 descendant of its own
- K253673: M•care System (MW-20) (2026), 0 descendants of its own
- K221046: Invu by Nuvo (2022), 0 descendants of its own
- K191401: PregSense (2020), 0 descendants of its own

## Recalls of this device
- Aug 4, 2016 · Class II · Z-2829-2016: Belt clip may become detached causing electronic components to be exposed.

## Indications for use
The Sense4Baby System Model B+ is indicated for conventional antepartum fetal monitoring applications in pregnancies greater than or equal to 24 weeks gestation. It may be used for antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring) in a health care setting or home. It is to be used by health care professionals and patients on the order of a physician. Before the Sense4Baby System Model B+ is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment. Home uterine activity monitoring has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

Source page: https://510kreport.com/device/K143114
Methodology: https://510kreport.com/methodology