Cleared Traditional

K812586 - KANTRON 504 HEARTSTATION

K812586 is an FDA 510(k) clearance for KANTRON 504 HEARTSTATION, manufactured by Kantron Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K812586 · Kantron Cardiovascular, Inc. · Cardiovascular device
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Dec 1981
Decision
109d
Days
Class 2
Risk

K812586 is an FDA 510(k) clearance for the KANTRON 504 HEARTSTATION. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Kantron Cardiovascular, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Kantron Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K812586

510(k) Number K812586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1981
Decision Date December 29, 1981
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 119
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K812586.
MODEL 78670A
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VPD-261 DEFIBRILLATOR MONITOR
K822294 · Life Science Instrumentation, Inc. · Aug 1982
LINE POWERED LOW ENERGY DEFIBRILLATOR II
K813471 · Narco Scientific · Dec 1981
2000 SERIES PORTABLE RESUSCITATION SYST.
K812519 · Life Science Instrumentation, Inc. · Sep 1981
280/4 MINI-DEFIBRILLATOR
K812520 · Life Science Instrumentation, Inc. · Sep 1981