Cleared Traditional

K190437 - Delta 3300

K190437 is the FDA 510(k) clearance for Delta 3300 by Netech Corporation. It is a Class 2 Cardiovascular device (product code DRL) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K190437 · Netech Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
187d
Days
Class 2
Risk

K190437 is an FDA 510(k) clearance for the Delta 3300. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by Netech Corporation (Farmingdale, US). The FDA issued a Cleared decision on August 28, 2019 after a review of 187 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 Corporation devices

Submission Details

510(k) Number K190437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2019
Decision Date August 28, 2019
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
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.

Regulatory Consultant

Brij Strategic Consultations, LLC
Mukesh Kumar

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRL Tester, Defibrillator

Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K190437.
UniPulse
K182905 · Seaward Group · Dec 2018
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
K954391 · Bio-Tek Instruments, Inc. · Nov 1995
DEFIBRILLATOR ANALYZER MODEL QED-5
K904159 · Bio-Tek Instruments, Inc. · Mar 1991
DEFIBRILLATOR INTERAL PADDLE TEST LOAD
K790394 · Physio-Control Corp. · Mar 1979
CARDIAC CARE Q/C TEST KIT
K782033 · Instrumentation Laboratory CO · Dec 1978