Cleared Special

K112448 - PULSIOFLEX

K112448 is an FDA 510(k) clearance for PULSIOFLEX, manufactured by Pulsion Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Special 510(k) pathway after a 28-day FDA review.

K112448 · Pulsion Medical Systems, Inc. · Cardiovascular device
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Sep 2011
Decision
28d
Days
Class 2
Risk

K112448 is an FDA 510(k) clearance for the PULSIOFLEX. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Pulsion Medical Systems, Inc. (Westbrook, US). The FDA issued a Cleared decision on September 22, 2011 after a review of 28 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 - K112448

510(k) Number K112448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2011
Decision Date September 22, 2011
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 123
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K112448 · PULSIOFLEX
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