Cleared Traditional

K062099 - PHASE 3, MODEL DT-1

K062099 is an FDA 510(k) clearance for PHASE 3, manufactured by Datrend Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRL cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K062099 · Datrend Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
185d
Days
Class 2
Risk

K062099 is an FDA 510(k) clearance for the PHASE 3, MODEL DT-1. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by Datrend Systems, Inc. (Richmond, British Columbia, CA). The FDA issued a Cleared decision on January 25, 2007 after a review of 185 days - an extended review cycle.

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. Standard predicate reliance. 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 - K062099

510(k) Number K062099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date January 25, 2007
Days to Decision 185 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
60d slower than avg
Panel avg: 125d · This submission: 185d
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 18
Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K062099.
DEFIBRILLATOR ANALYZER - DA-2006P
K110192 · Bc Group International, Inc. · Feb 2011
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
K083347 · Fluke Biomedical · Dec 2008
IMPULSE 6000D/7000DP
K072114 · Fluke Biomedical · Jan 2008
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
K030547 · Guardian Angel Products, Inc. · Jul 2003
QA-40M DEFIBRILLATOR TESTER
K963190 · Metron U.S., Inc. · Jul 1997
DEFIBRILLATOR ANALYZER, DELTA 1000
K961595 · Netech Corp. · Oct 1996
K062099 · PHASE 3, MODEL DT-1
Download PDF FDA Summary Datrend Systems, Inc.