Cleared Traditional

K954609 - HEARTSTART 911

K954609 is an FDA 510(k) clearance for HEARTSTART 911, manufactured by Laerdal Medical Corp.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K954609 · Laerdal Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
92d
Days
Class 3
Risk

K954609 is an FDA 510(k) clearance for the HEARTSTART 911. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Laerdal Medical Corp. (Wappingers Falls, US). The FDA issued a Cleared decision on January 4, 1996 after a review of 92 days - within the typical 510(k) review window.

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 Laerdal Medical Corp. devices

FDA 510(k) Submission Details - K954609

510(k) Number K954609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1995
Decision Date January 04, 1996
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

MKJ Device Classification - Class 3, Premarket Approval

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)

All 170
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K954609.
DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
K960329 · Contour Medical Technology, Inc. · Jul 1996
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION
K954957 · Hewlett-Packard Co. · May 1996
PEDIATRIC QUIK-COMBO
K953204 · Physio-Control Corp. · Jan 1996
K-DEFIB/PACE PEDIATRIC ELECTRODE
K954504 · Katecho, Inc. · Nov 1995
MARQUETTE DEFIB ELECTRODES
K952101 · Marquette Electronics, Inc. · Sep 1995
MARQUETTE DEFIB ELECTRODE
K941262 · Marquette Electronics, Inc. · Apr 1995