Cleared Traditional

K963190 - QA-40M DEFIBRILLATOR TESTER

K963190 is an FDA 510(k) clearance for QA-40M DEFIBRILLATOR TESTER, manufactured by Metron U.S., Inc.. The device is a Class 2 Cardiovascular device with product code DRL cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K963190 · Metron U.S., Inc. · Cardiovascular device
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Jul 1997
Decision
320d
Days
Class 2
Risk

K963190 is an FDA 510(k) clearance for the QA-40M DEFIBRILLATOR TESTER. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by Metron U.S., Inc. (Grand Rapids, US). The FDA issued a Cleared decision on July 1, 1997 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5325 - 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: Standard predicate-based submission. Elevated predicate reliance 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.

FDA 510(k) Submission Details - K963190

510(k) Number K963190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1996
Decision Date July 01, 1997
Days to Decision 320 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 125d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 17
Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K963190.
IMPULSE 6000D/7000DP
K072114 · Fluke Biomedical · Jan 2008
PHASE 3, MODEL DT-1
K062099 · Datrend Systems, Inc. · Jan 2007
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
K030547 · Guardian Angel Products, Inc. · Jul 2003
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
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
K941404 · Hogan & Hartson · Jun 1994
K963190 · QA-40M DEFIBRILLATOR TESTER
Download PDF Metron U.S., Inc.