System 37 Home Uterine Activity Monitor
PMA P920038
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP920038 | Date29 Sep 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- System 37 Home Uterine Activity Monitoring System
- Generic Name
- Home uterine activity monitor
- PMA Number
- FDA Product Code
- LQK
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The System 37 Home Uterine Activity Monitor is a Class II medical device designed for continuous, non-invasive monitoring of uterine contractions and fetal heart rate at home. It provides real-time data to assess labor progression and fetal well-being, supporting clinical decision-making in obstetric care.
This device is supplied as a reusable system with disposable sensors and is intended for use in home settings under medical supervision. It requires FDA approval (PMA P920038) and is classified under regulation number 884.2730 for obstetrics/gynecology applications. Proper storage and maintenance are essential to ensure accurate monitoring and compliance with regulatory standards.
Other devices from Matria Healthcare, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the SYSTEM 37 Home Uterine Activity Monitoring System, and how does it differ from traditional hospital-based monitoring?
The SYSTEM 37 is designed for continuous, non-invasive monitoring of uterine contractions and fetal heart rate in a home setting, allowing clinicians to track labor progression and fetal well-being remotely. Unlike hospital-based monitors, it enables real-time data transmission from home, supporting medical supervision outside the clinical environment while maintaining accuracy for obstetric decision-making.
Is the SYSTEM 37 reusable, and if so, what components are disposable?
Yes, the SYSTEM 37 is supplied as a reusable system, but it requires disposable sensors for each use. This design balances cost efficiency with hygiene, ensuring accurate monitoring while minimizing cross-contamination risks between patients.
What regulatory approval does the SYSTEM 37 hold, and how does that affect its use?
The SYSTEM 37 holds FDA Premarket Approval (PMA P920038), meaning it has undergone rigorous review to demonstrate safety and effectiveness for its intended use in obstetrics/gynecology (regulation 884.2730). This approval ensures compliance with U.S. regulatory standards for home uterine monitoring under medical supervision.
How should the SYSTEM 37 be stored to maintain its functionality and accuracy?
Proper storage is critical for performance and compliance. While exact storage conditions aren’t detailed here, the manufacturer emphasizes maintenance protocols to preserve accuracy—likely including protection from moisture, extreme temperatures, and physical damage. Always follow the included instructions to ensure reliable monitoring.