Cleared Traditional

K171620 - PiCCO Catheter

K171620 is the FDA 510(k) clearance for PiCCO Catheter by Pulsion Medical Systems SE. It is a Class 2 Cardiovascular device (product code KRB) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K171620 · Pulsion Medical Systems SE · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
264d
Days
Class 2
Risk

K171620 is an FDA 510(k) clearance for the PiCCO Catheter. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Pulsion Medical Systems SE (Feldkirchen, DE). The FDA issued a Cleared decision on February 21, 2018 after a review of 264 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Pulsion Medical Systems SE devices

Submission Details

510(k) Number K171620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2017
Decision Date February 21, 2018
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 125d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Getinge
Mark Dinger

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRB Probe, Thermodilution

All 14
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K171620.
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · Edwards Lifesciences, LLC · Dec 2010
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · Ohmeda Medical · Mar 1994
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893 · NuMED, Inc. · Sep 1988
ACKRAD TDI SET
K864818 · Ackrad Laboratories · Apr 1987
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · Sorensen Research · Oct 1981