Cleared Traditional

K831977 - C TEC SERIES 9000 E.C.G. ELECTRODE

K831977 is an FDA 510(k) clearance for C TEC SERIES 9000 E.C.G. ELECTRODE, manufactured by Speywood Medical, Ltd.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K831977 · Speywood Medical, Ltd. · Cardiovascular device
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Sep 1983
Decision
81d
Days
Class 2
Risk

K831977 is an FDA 510(k) clearance for the C TEC SERIES 9000 E.C.G. ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Speywood Medical, Ltd. (Walker, US). The FDA issued a Cleared decision on September 9, 1983 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight 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 Speywood Medical, Ltd. devices

FDA 510(k) Submission Details - K831977

510(k) Number K831977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1983
Decision Date September 09, 1983
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 197
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K831977.
ESOPHOGRAL MULTIPROBE
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ADULT MONITORING ELECTOR@@RODE 9431-300
K833695 · Marquette Electronics, Inc. · Jan 1984
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K830655 · Quinton, Inc. · Jun 1983
MEDI-TRACE 5' OFFSET ELECTRODE
K822750 · Graphic Controls Corp. · Nov 1982
DISPOSABLE ELECTRODE #1900
K822798 · Andover Medical, Inc. · Oct 1982