Cleared Traditional

FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS (K955628) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K955628 · Heartstream, Inc. · Cardiovascular device
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Sep 1996
Decision
274d
Days
Class 3
Risk

K955628 is an FDA 510(k) clearance for the FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Heartstream, Inc. (Seattle, US). The FDA issued a Cleared decision on September 10, 1996 after a review of 274 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Heartstream, Inc. devices

Submission Details

510(k) Number K955628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date September 10, 1996
Days to Decision 274 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 125d · This submission: 274d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - MKJ Automated External Defibrillators (non-wearable)

Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K955628.
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
K991871 · Hewlett-Packard Co. · Aug 1999
HEARTSTREAM ELECTRODE ADAPTER
K984286 · Hewlett-Packard Co. · Dec 1998
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR
K982025 · Hewlett-Packard Co. · Sep 1998
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION
K954957 · Hewlett-Packard Co. · May 1996