Cleared Traditional

K801800 - UNIVERSAL TEMP. PACING ELECT. #080-10000

K801800 is the FDA 510(k) clearance for UNIVERSAL TEMP. PACING ELECT. #080-10000 by Medical Testing System, Inc.. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K801800 · Medical Testing System, Inc. · Cardiovascular device
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Oct 1980
Decision
86d
Days
Class 2
Risk

K801800 is an FDA 510(k) clearance for the UNIVERSAL TEMP. PACING ELECT. #080-10000. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medical Testing System, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Medical Testing System, Inc. devices

Submission Details

510(k) Number K801800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1980
Decision Date October 23, 1980
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 82
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K801800.
ELECATH DUAL MODE TRANSTHORACIC PACING
K810312 · Electro-Catheter Corp. · Mar 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041 · Cordis Corp. · Feb 1981
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
K803058 · American Edwards Laboratories · Jan 1981
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · C.R. Bard, Inc. · Apr 1980
SWAN-GANZ FLOW-DIRECTED CATHETER
K791183 · Edwards Lifesciences, LLC · Jul 1979
TEMPORARY CARDIAC PACING WIRE
K781002 · Ethicon, Inc. · Dec 1978