Cleared Special

K012020 - RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC

K012020 is an FDA 510(k) clearance for RESPIEVENTS SOFTWARE IS EVENT DATA PROC..., manufactured by Non-Invasive Monitoring Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 54-day FDA review.

K012020 · Non-Invasive Monitoring Systems, Inc. · Cardiovascular device
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Aug 2001
Decision
54d
Days
Class 2
Risk

K012020 is an FDA 510(k) clearance for the RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Non-Invasive Monitoring Systems, Inc. (Miami Beach, US). The FDA issued a Cleared decision on August 21, 2001 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Non-Invasive Monitoring Systems, Inc. devices

FDA 510(k) Submission Details - K012020

510(k) Number K012020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2001
Decision Date August 21, 2001
Days to Decision 54 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 333
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K012020.
MAC 5000 ECG ANALYSIS SYSTEM
K014108 · General Electric Medical Systems Information Techn · Jan 2002
CARTO XP EP NAVIGATION SYSTEM
K013083 · Biosense Webster, Inc. · Nov 2001
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
K012206 · Cambridge Heart, Inc. · Oct 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · Cambridge Heart, Inc. · May 2001
SYNETEC
K002817 · Ela Medical, Inc. · May 2001
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K010756 · Cambridge Heart, Inc. · Apr 2001