Cleared Traditional

K812586 - KANTRON 504 HEARTSTATION

K812586 is the FDA 510(k) clearance for KANTRON 504 HEARTSTATION by Kantron Cardiovascular, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 50
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K812586.
PORTABLE DEFIBRILLATOR MONITOR 74DRK
K831696 · Honeywell, Inc. · Nov 1983
THERACARD 400
K823828 · Siemens Medical Solutions USA, Inc. · Mar 1983
MODEL 78670A
K823268 · Hewlett-Packard Co. · Jan 1983
DEFIBRILLATOR/MONITOR
K812317 · Hewlett-Packard Co. · Sep 1981
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
K811638 · Datascope Corp. · Jul 1981
PORTABLE, BATTERY OPERATED DEFIBRILLATOR
K810237 · Honeywell, Inc. · Feb 1981