MGD-3 Fetal Ultrasonic Monitor
by Kt Medical, Inc. 510(k)
Active
510(k) K800095
Overview
The MGD-3 is a Monitor, Ultrasonic, Fetal, designed to evaluate fetal heart rate and uterine contractions during pregnancy. This Class II device employs ultrasonic technology to provide real-time monitoring of fetal well-being, supporting clinical assessments in obstetric settings. Its primary function aligns with obstetrics/gynecology applications, where continuous or intermittent fetal surveillance is critical. The device adheres to FDA-recognized standards for fetal monitoring, ensuring compliance with regulatory requirements for diagnostic accuracy and safety.
The MGD-3 is supplied as a reusable medical device, intended for use in clinical environments such as hospitals, birthing centers, or obstetric clinics. It operates under non-sterile conditions for routine monitoring but may require cleaning and maintenance per manufacturer guidelines. The device is classified under FDA regulation 884.2660 and holds a Traditional 510(k) clearance (K800095) for obstetrics/gynecology applications. No specific MRI safety classification or single-use designation is noted in the regulatory records.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800095 | Date11 Feb 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Mgd-3
- 510(k) Number
- FDA Product Code
- KNG
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2660
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kt Medical, Inc.
Questions
What is the MGD-3 fetal monitor used for?
The MGD-3 is designed to evaluate fetal heart rate and uterine contractions during pregnancy. This real-time monitoring supports clinical assessments in obstetrics/gynecology, helping healthcare providers assess fetal well-being in settings like hospitals, birthing centers, or obstetric clinics. Its ultrasonic technology ensures accurate diagnostic evaluation as part of routine fetal surveillance.
Is the MGD-3 a single-use or reusable device?
The MGD-3 is a reusable medical device. It is intended for use in clinical environments where proper cleaning and maintenance per manufacturer guidelines are required. This design allows for repeated use across multiple patients, provided the device remains functional and adheres to hygiene protocols.
What regulatory approval does the MGD-3 hold?
The MGD-3 holds a Traditional 510(k) clearance (K800095) from the FDA under regulation 884.2660. This clearance confirms its substantial equivalence to a predicate device and compliance with FDA-recognized standards for fetal monitoring in obstetrics/gynecology applications. The device is classified as Class II, reflecting its role in diagnostic procedures.
How should the MGD-3 be stored?
While the MGD-3 is intended for non-sterile use during routine monitoring, proper storage is critical to maintain its functionality and hygiene. The device should be stored in a clean, dry environment, protected from physical damage or contamination. Follow the manufacturer’s guidelines for cleaning, maintenance, and storage to ensure optimal performance and longevity.
Does the MGD-3 have any specific MRI safety classification?
The regulatory records for the MGD-3 do not specify an MRI safety classification. If MRI compatibility is required in your clinical setting, verify with the manufacturer or consult their technical documentation to ensure safe use in proximity to MRI equipment. Always follow facility protocols for devices without explicit MRI clearance.