Cleared Traditional

K943732 - LIFE TRACE FETAL SPIRAL ELECTRODE WITH ...

K943732 is the FDA 510(k) clearance for LIFE TRACE FETAL SPIRAL ELECTRODE WITH ... by Graphic Controls Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HGP) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K943732 · Graphic Controls Corp. · Obstetrics & Gynecology device
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Oct 1994
Decision
79d
Days
Class 2
Risk

K943732 is an FDA 510(k) clearance for the LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE. Classified as Electrode, Circular (spiral), Scalp And Applicator (product code HGP), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buffalo, US). The FDA issued a Cleared decision on October 20, 1994 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Graphic Controls Corp. devices

Submission Details

510(k) Number K943732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1994
Decision Date October 20, 1994
Days to Decision 79 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 160d · This submission: 79d
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.

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

All 7
Devices cleared under the same product code (HGP) and FDA review panel - the closest regulatory comparables to K943732.
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