Cleared Traditional

SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (K994353) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994353 · Precision Dynamics Corp. · Obstetrics & Gynecology device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994353 is an FDA 510(k) clearance for the SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Precision Dynamics Corp. (San Fernando, US). The FDA issued a Cleared decision on March 22, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K994353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date March 22, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFM Monitor, Uterine Contraction, External (for Use In Clinic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.