Cleared Special

K072364 - PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

K072364 is an FDA 510(k) clearance for PULSION PULSIOCATH THERMODILUTION CATHE..., manufactured by Pulsion Medical Systems AG. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Special 510(k) pathway after a 28-day FDA review.

K072364 · Pulsion Medical Systems AG · Cardiovascular device
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Sep 2007
Decision
28d
Days
Class 2
Risk

K072364 is an FDA 510(k) clearance for the PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Pulsion Medical Systems AG (Wake Forest, US). The FDA issued a Cleared decision on September 19, 2007 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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 - K072364

510(k) Number K072364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2007
Decision Date September 19, 2007
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KRB Device Classification - Class 2, Special Controls

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
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 - KRB Probe, Thermodilution

All 32
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K072364.
PiCCO Catheter
K171620 · Pulsion Medical Systems SE · Feb 2018
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · Edwards Lifesciences, LLC · Dec 2010
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
K020587 · Pulsion Medical Systems AG · May 2002
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
K991886 · Pulsion Medical Systems, Inc. · May 2000
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · Ohmeda Medical · Mar 1994
PACEVIEW
K915627 · Micromedical Industries, Ltd. · Mar 1992
K072364 · PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
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