Cleared Traditional

K905130 - FETAL MONITORING SPIRAL ELECTRODE

K905130 is the FDA 510(k) clearance for FETAL MONITORING SPIRAL ELECTRODE by Graphic Controls Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HGP) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K905130 · Graphic Controls Corp. · Obstetrics & Gynecology device
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Jan 1991
Decision
75d
Days
Class 2
Risk

K905130 is an FDA 510(k) clearance for the FETAL MONITORING SPIRAL ELECTRODE. 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 January 29, 1991 after a review of 75 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 K905130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date January 29, 1991
Days to Decision 75 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 160d · This submission: 75d
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 K905130.
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
MULTI-PRONG FETAL SCALP ELECTRODE
K822584 · Kontron Instruments, Inc. · Feb 1983
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
K792669 · Ge Medical Systems Information Technologies · Feb 1980
SPIRAL SCALP ELECTRODE, 14499A
K771553 · Hewlett-Packard Co. · Aug 1977