Cleared Traditional

K003458 - SOFT BEAT FETAL HEART RATE ELECTRODE MO...

K003458 is an FDA 510(k) clearance for SOFT BEAT FETAL HEART RATE ELECTRODE MO..., manufactured by Clinical Innovations, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGP cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K003458 · Clinical Innovations, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
177d
Days
Class 2
Risk

K003458 is an FDA 510(k) clearance for the SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000. Classified as Electrode, Circular (spiral), Scalp And Applicator (product code HGP), Class II - Special Controls.

Submitted by Clinical Innovations, Inc. (Murray, US). The FDA issued a Cleared decision on May 3, 2001 after a review of 177 days - an extended review cycle.

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.

View all Clinical Innovations, Inc. devices

FDA 510(k) Submission Details - K003458

510(k) Number K003458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2000
Decision Date May 03, 2001
Days to Decision 177 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 160d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HGP Electrode, Circular (spiral), Scalp And Applicator

All 8
Devices cleared under the same product code (HGP) and FDA review panel - the closest regulatory comparables to K003458.
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
K243291 · Neoventa Medical AB · Jan 2025
LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
K943732 · Graphic Controls Corp. · Oct 1994
COMBO FETAL SCALP ELECTRODE/LEGPLATE
K905830 · Utah Medical Products, Inc. · Mar 1991
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE
K904745 · Graphic Controls Corp. · Jan 1991
FETAL MONITORING SPIRAL ELECTRODE
K905130 · Graphic Controls Corp. · Jan 1991
MULTI-PRONG FETAL SCALP ELECTRODE
K822584 · Kontron Instruments, Inc. · Feb 1983