Cleared Special

K030547 - MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE

K030547 is an FDA 510(k) clearance for MODIFICATION TO ZAP GUARD DEFIBRILLATOR..., manufactured by Guardian Angel Products, Inc.. The device is a Class 2 Cardiovascular device with product code DRL cleared through the Special 510(k) pathway after a 141-day FDA review.

K030547 · Guardian Angel Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K030547

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

DRL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DRL Tester, Defibrillator

All 18
Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K030547.
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
K083347 · Fluke Biomedical · Dec 2008
IMPULSE 6000D/7000DP
K072114 · Fluke Biomedical · Jan 2008
PHASE 3, MODEL DT-1
K062099 · Datrend Systems, Inc. · Jan 2007
QA-40M DEFIBRILLATOR TESTER
K963190 · Metron U.S., Inc. · Jul 1997
DEFIBRILLATOR ANALYZER, DELTA 1000
K961595 · Netech Corp. · Oct 1996
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
K954391 · Bio-Tek Instruments, Inc. · Nov 1995
K030547 · MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
Download PDF FDA Summary Guardian Angel Produc…