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Secureline Disposable Fetal Monitoring Straps #3860 and #3565

FDA 510(k)

Class II (US FDA 510(k))

510(k) K994353

by Precision Dynamics Corp.

Identifiers

510(k) Number
K994353 FDA 510(k)
FDA Product Code
HFM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.2720 FDA 510(k)
Regulation Number
884.2720 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Secureline Disposable Fetal Monitoring Straps #3860 and #3565 are external uterine contraction monitors designed for single-patient use. These disposable straps secure fetal heart rate transducers and contraction monitors to the maternal abdomen, enabling continuous monitoring of fetal heart rate and uterine contractions during labor.

Intended for use in labor and delivery settings, these straps are single-use devices. They are classified as FDA Class II medical devices with a 510(k) clearance under the Obstetrics/Gynecology advisory committee. Each strap model (#3860 and #3565) is supplied sterile and intended for one-time use per patient to ensure hygiene and safety.

Frequently asked questions

What are the Secureline Disposable Fetal Monitoring Straps #3860 and #3565 primarily used for in a clinical setting?

These straps are designed as external uterine contraction monitors to secure fetal heart rate transducers and contraction sensors to the maternal abdomen during labor. They enable continuous monitoring of both fetal heart rate and uterine contractions, which is critical for assessing fetal well-being and guiding obstetric care in labor and delivery settings.

Are the Secureline Disposable Fetal Monitoring Straps #3860 and #3565 intended for reuse, or are they single-use devices?

The straps are explicitly single-use devices, intended for one-time use per patient. This design ensures hygiene and safety by preventing cross-contamination between patients, which is particularly important in labor and delivery environments where sterility is paramount.

How are the Secureline Disposable Fetal Monitoring Straps #3860 and #3565 supplied, and what does that mean for their handling?

Both models (#3860 and #3565) are supplied sterile and packaged for single-patient use. This means they are pre-sterilized by the manufacturer and should be handled using aseptic techniques—opening the packaging only immediately before use and discarding any unused portions after application to maintain sterility and compliance with infection control protocols.

What regulatory pathway was followed for FDA clearance of these fetal monitoring straps, and what does that imply for their safety and equivalence?

The Secureline Disposable Fetal Monitoring Straps underwent a 510(k) clearance process through the FDA’s Obstetrics/Gynecology advisory committee, with a decision labeled as *Substantially Equivalent* (SESE). This implies that the device was determined to have the same intended use, technological characteristics, and safety profile as a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness in external uterine contraction monitoring.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Secureline Disposable Fetal Monitoring Straps #3860 and #3565, SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 by ..., Secureline Disposable Fetal Monitoring Straps #3860 and #3565, Secureline Disposable Fetal Monitoring Straps #3860 and #3565

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Precision Dynamics Corp.

Sources (1)

  • FDA 510(k) K994353 24 fields · synced Oct 6, 2026