Cleared Special

K102168 - SENSEI X ROBOTIC CATHETER SYSTEM

K102168 is an FDA 510(k) clearance for SENSEI X ROBOTIC CATHETER SYSTEM, manufactured by Hansen Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Special 510(k) pathway after a 81-day FDA review.

K102168 · Hansen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
81d
Days
Class 2
Risk

K102168 is an FDA 510(k) clearance for the SENSEI X ROBOTIC CATHETER SYSTEM. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Hansen Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - 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 - K102168

510(k) Number K102168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date October 22, 2010
Days to Decision 81 days
Submission Type Special
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
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
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 - DXX System, Catheter Control, Steerable

All 32
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K102168.
CORPATH 200 SYSTEM
K120834 · Corindus, Inc. · Jul 2012
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K113628 · Catheter Robotics, Inc. · Jun 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004 · Hansen Medical, Inc. · May 2012
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
K091808 · Hansen Medical, Inc. · Sep 2009
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
K090365 · Hansen Medical, Inc. · May 2009
SENSEI CATHETER CONTROL SYSTEM
K073225 · Hansen Medical, Inc. · Jun 2008