Cleared Traditional

K800286 - CRITERION II PACING SYSTEM MONITORS

K800286 is an FDA 510(k) clearance for CRITERION II PACING SYSTEM MONITORS, manufactured by Dart Medical Equipment. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K800286 · Dart Medical Equipment · Cardiovascular device
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Mar 1980
Decision
33d
Days
Class 2
Risk

K800286 is an FDA 510(k) clearance for the CRITERION II PACING SYSTEM MONITORS. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Dart Medical Equipment (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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 Dart Medical Equipment devices

FDA 510(k) Submission Details - K800286

510(k) Number K800286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1980
Decision Date March 12, 1980
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTC Device Classification - Class 2, Special Controls

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
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 - DTC Analyzer, Pacemaker Generator Function

All 27
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K800286.
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · Medtronic Vascular · Jun 1982
ELECTRODE/PACER SYSTEM ANALYZER PMA 400
K810604 · Telectronics, Inc. · Apr 1981
SUSI II PACEMAKER SURVEILLANCE MONITOR
K792602 · Ela Medical, Inc. · Mar 1980
PACING SYSTEM ANALYZER PSA SCE-22
K791975 · Ela Medical, Inc. · Jan 1980
MODEL 674 PACER ANALYZER
K792074 · Del Mar Avionics · Dec 1979
SELF CHECK
K791762 · Instromedix, Inc. · Sep 1979