Cleared Traditional

AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE (K032421) - FDA 510(k) Clearance

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

K032421 · Ambu, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
206d
Days
Class 3
Risk

K032421 is an FDA 510(k) clearance for the AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on February 27, 2004 after a review of 206 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 Ambu, Inc. devices

Submission Details

510(k) Number K032421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2003
Decision Date February 27, 2004
Days to Decision 206 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 125d · This submission: 206d
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 24
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K032421.
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
K050004 · Philips Medical Systems · Feb 2005
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
K040479 · Welch Allyn, Inc. · Sep 2004
HEARTSTART MRX, MODEL M3535A
K040404 · Philips Medical Systems, Inc. · May 2004
HEARTSTART MRX, MODEL M3535A
K031187 · Philips Medical Systems · Aug 2003
PHILIPS M5066A AND M5068A
K020715 · Philips Medical Systems · Nov 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453 · Philips Medical Systems · Jul 2002