Cleared Special

K072919 - VENDYS, MODEL 6000 B B/C

K072919 is an FDA 510(k) clearance for VENDYS, manufactured by Endothelix, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 18-day FDA review.

K072919 · Endothelix, Inc. · Cardiovascular device
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Nov 2007
Decision
18d
Days
Class 2
Risk

K072919 is an FDA 510(k) clearance for the VENDYS, MODEL 6000 B B/C. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Endothelix, Inc. (Houston, US). The FDA issued a Cleared decision on November 2, 2007 after a review of 18 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 Endothelix, Inc. devices

FDA 510(k) Submission Details - K072919

510(k) Number K072919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2007
Decision Date November 02, 2007
Days to Decision 18 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
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 320
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