Cleared Special

K072735 - PULSION PICCO-2, MODEL 8500

K072735 is an FDA 510(k) clearance for PULSION PICCO-2, manufactured by Pulsion Medical Systems AG. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Special 510(k) pathway after a 21-day FDA review.

K072735 · Pulsion Medical Systems AG · Cardiovascular device
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Oct 2007
Decision
21d
Days
Class 2
Risk

K072735 is an FDA 510(k) clearance for the PULSION PICCO-2, MODEL 8500. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Pulsion Medical Systems AG (Wake Forest, US). The FDA issued a Cleared decision on October 18, 2007 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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.

FDA 510(k) Submission Details - K072735

510(k) Number K072735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date October 18, 2007
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 157
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K072735 · PULSION PICCO-2, MODEL 8500
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