Cleared Traditional

DEFIBRILLATOR ANALYZER, DELTA 1000 (K961595) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961595 · Netech Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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.