Toco Transducer
by Scientific Device Manufacturer, LLC
510(k) K952579
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952579 | Date4 Aug 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HFM
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2720
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Monitor, Uterine Contraction, External (For Use In Clinic), classified under the FDA’s Device Class 2 regulatory framework. It is designed to detect and monitor uterine contractions during pregnancy, providing real-time data on fetal activity and maternal labor progression. The transducer operates externally on the maternal abdomen, using piezoelectric technology to convert mechanical vibrations into electrical signals for analysis. Its primary purpose is clinical observation in obstetrics, aiding in the assessment of fetal well-being and labor dynamics.
The Toco Transducer is supplied as a reusable medical device, intended for use in clinical settings such as hospitals or birthing centers. It is not sterile upon packaging and must be cleaned and disinfected between uses according to standard infection control protocols. The device adheres to FDA 510(k) clearance (K952579) under the HFM (Hospital Furniture and Equipment) product code, with regulatory oversight under 21 CFR 884.2720. Compatibility with fetal monitoring systems is manufacturer-specified, and its design ensures durability for repeated clinical use in obstetric care.
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Questions
AI-generated answers, 1 Oct 2026
What is the Toco Transducer used for in clinical settings?
The Toco Transducer is designed to detect and monitor uterine contractions externally during pregnancy. By placing it on the maternal abdomen, it converts mechanical vibrations into electrical signals, enabling real-time analysis of fetal activity and labor progression. This aids clinicians in assessing fetal well-being and labor dynamics in obstetric care.
Is the Toco Transducer sterile upon packaging?
No, the Toco Transducer is not sterile when supplied. It is classified as a reusable medical device, so it must be thoroughly cleaned and disinfected between uses following standard infection control protocols to ensure patient safety and device longevity.
How is the Toco Transducer regulated and approved?
The Toco Transducer holds FDA 510(k) clearance under the product code HFM (Hospital Furniture and Equipment), with regulatory oversight under 21 CFR 884.2720. It was determined substantially equivalent to a predicate device by the Obstetrics/Gynecology Advisory Committee in 1995, ensuring compliance with U.S. medical device regulations.
What type of technology does the Toco Transducer use?
The Toco Transducer employs piezoelectric technology, which converts mechanical vibrations from uterine contractions into electrical signals. These signals are then processed by compatible fetal monitoring systems to provide real-time data for clinical assessment.
Can the Toco Transducer be used with any fetal monitoring system?
Compatibility with fetal monitoring systems is manufacturer-specified. While the Toco Transducer is designed to work with standard obstetric monitoring equipment, users should verify compatibility with their specific system to ensure accurate data acquisition and analysis.