Cleared Traditional

K992543 - HEARTSTREAM XLT DEFIBRILLATOR/MONITOR

K992543 is the FDA 510(k) clearance for HEARTSTREAM XLT DEFIBRILLATOR/MONITOR by Hewlett-Packard Co.. It is a Class 3 Cardiovascular device (product code MKJ) cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K992543 · Hewlett-Packard Co. · Cardiovascular device
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May 2000
Decision
293d
Days
Class 3
Risk

K992543 is an FDA 510(k) clearance for the HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SIN.... Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Hewlett-Packard Co. (Seattle, US). The FDA issued a Cleared decision on May 18, 2000 after a review of 293 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K992543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date May 18, 2000
Days to Decision 293 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 125d · This submission: 293d
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)

All 87
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K992543.
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
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HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
K003565 · Agilent Technologies, Inc. · Dec 2000
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
K001725 · Agilent Technologies, Inc. · Sep 2000
ZOLL M SERIES ETCO2 OPTION
K993036 · Zoll Medical Corp · Feb 2000
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977 · Hewlett-Packard Co. · Dec 1999
ZOLL M SERIES 12SL ANALYSIS OPTION
K991556 · Zoll Medical Corp · Oct 1999