Cleared Traditional

K040904 - PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A

K040904 is an FDA 510(k) clearance for PHILIPS HEARTSTART HOME DEFIBRILLATOR, manufactured by Philips Medical Systems. The device is a Class 3 Cardiovascular device with product code NSA cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K040904 · Philips Medical Systems · Cardiovascular device
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Sep 2004
Decision
162d
Days
Class 3
Risk

K040904 is an FDA 510(k) clearance for the PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A. Classified as Over-the-counter Automated External Defibrillator (product code NSA), Class III - Premarket Approval.

Submitted by Philips Medical Systems (Seattle, US). The FDA issued a Cleared decision on September 16, 2004 after a review of 162 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 Philips Medical Systems devices

FDA 510(k) Submission Details - K040904

510(k) Number K040904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2004
Decision Date September 16, 2004
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

NSA Device Classification - Class 3, Premarket Approval

Product Code NSA Over-the-counter Automated External Defibrillator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition Automated External Defibrillators Are Devices That 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 Over-the-counter Without A Prescription. The Device Is To Be Used On Adults And Children Who Are Either > 8 Years Old Or > 55 Lbs.
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.