Cleared Special

K993620 - IMPRESARIO

K993620 is an FDA 510(k) clearance for IMPRESARIO, manufactured by Del Mar Medical Systems, LLC. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 17-day FDA review.

K993620 · Del Mar Medical Systems, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
17d
Days
Class 2
Risk

K993620 is an FDA 510(k) clearance for the IMPRESARIO. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Del Mar Medical Systems, LLC (Irvine, US). The FDA issued a Cleared decision on November 12, 1999 after a review of 17 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 Del Mar Medical Systems, LLC devices

FDA 510(k) Submission Details - K993620

510(k) Number K993620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1999
Decision Date November 12, 1999
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 359
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K993620.
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K990956 · Biosensor Corp. · Jun 1999