Cleared Traditional

K801984 - FE-3000 FETAL ELECTRODE

K801984 is the FDA 510(k) clearance for FE-3000 FETAL ELECTRODE by Life Support, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGP) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K801984 · Life Support, Inc. · Obstetrics & Gynecology device
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Sep 1980
Decision
21d
Days
Class 2
Risk

K801984 is an FDA 510(k) clearance for the FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM. Classified as Electrode, Circular (spiral), Scalp And Applicator (product code HGP), Class II - Special Controls.

Submitted by Life Support, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 21 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 Life Support, Inc. devices

Submission Details

510(k) Number K801984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date September 09, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d faster than avg
Panel avg: 160d · This submission: 21d
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 8
Devices cleared under the same product code (HGP) and FDA review panel - the closest regulatory comparables to K801984.
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
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
K792669 · Ge Medical Systems Information Technologies · Feb 1980
SPIRAL SCALP ELECTRODE, 14499A
K771553 · Hewlett-Packard Co. · Aug 1977