Cleared Special

MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (K030547) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030547 · Guardian Angel Products, Inc. · Cardiovascular device
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Jul 2003
Decision
141d
Days
Class 2
Risk

K030547 is an FDA 510(k) clearance for the MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by Guardian Angel Products, Inc. (Huntingdon Valley, US). The FDA issued a Cleared decision on July 11, 2003 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5325 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Guardian Angel Products, Inc. devices

Submission Details

510(k) Number K030547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2003
Decision Date July 11, 2003
Days to Decision 141 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRL Tester, Defibrillator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5325
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.