Cleared Traditional

K243291 - Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (FDA 510(k) Clearance)

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

K243291 · Neoventa Medical AB · Obstetrics & Gynecology device
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Jan 2025
Decision
91d
Days
Class 2
Risk

K243291 is an FDA 510(k) clearance for the Goldtrace Fetal Spiral Electrode (FSE) (CNS000004). Classified as Electrode, Circular (spiral), Scalp And Applicator (product code HGP), Class II - Special Controls.

Submitted by Neoventa Medical AB (Mölndal, SE). The FDA issued a Cleared decision on January 17, 2025 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2675 - 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 K243291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2024
Decision Date January 17, 2025
Days to Decision 91 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 160d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGP Electrode, Circular (spiral), Scalp And Applicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2675
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.