Cleared Traditional

K961595 - DEFIBRILLATOR ANALYZER, DELTA 1000

K961595 is an FDA 510(k) clearance for DEFIBRILLATOR ANALYZER, manufactured by Netech Corp.. The device is a Class 2 Cardiovascular device with product code DRL cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K961595 · Netech Corp. · Cardiovascular device
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Oct 1996
Decision
188d
Days
Class 2
Risk

K961595 is an FDA 510(k) clearance for the DEFIBRILLATOR ANALYZER, DELTA 1000. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by Netech Corp. (Sound Beach, US). The FDA issued a Cleared decision on October 29, 1996 after a review of 188 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.

View all Netech Corp. devices

FDA 510(k) Submission Details - K961595

510(k) Number K961595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date October 29, 1996
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 9
Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K961595.
UniPulse
K182905 · Seaward Group · Dec 2018
DEFIBRILLATOR ANALYZER - DA-2006P
K110192 · Bc Group International, Inc. · Feb 2011
QA-40M DEFIBRILLATOR TESTER
K963190 · Metron U.S., Inc. · Jul 1997
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
DEFIBRILLATOR ANALYZER MODEL QED-5
K904159 · Bio-Tek Instruments, Inc. · Mar 1991