Cleared Special

K122121 - PULSIOFLEX MONITORING SYSTEM WITH PICCO...

K122121 is the FDA 510(k) clearance for PULSIOFLEX MONITORING SYSTEM WITH PICCO... by Pulsion Medical Systems SE. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Special 510(k) pathway after a 16-day FDA review.

K122121 · Pulsion Medical Systems SE · Cardiovascular device
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Aug 2012
Decision
16d
Days
Class 2
Risk

K122121 is an FDA 510(k) clearance for the PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Pulsion Medical Systems SE (Westbrook, US). The FDA issued a Cleared decision on August 2, 2012 after a review of 16 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.

View all Pulsion Medical Systems SE devices

Submission Details

510(k) Number K122121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2012
Decision Date August 02, 2012
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 77
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