Cleared Special

K141822 - SENSEI X ROBOTIC CATHETER SYSTEM

K141822 is an FDA 510(k) clearance for SENSEI X ROBOTIC CATHETER SYSTEM, manufactured by Hanson Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Special 510(k) pathway after a 29-day FDA review.

K141822 · Hanson Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
29d
Days
Class 2
Risk

K141822 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 Hanson Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 5, 2014 after a review of 29 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 - K141822

510(k) Number K141822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date August 05, 2014
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K141822.
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530 · Stereotaxis, Inc. · Dec 2014
VDRIVE WITH V-LOOP/ VDRIVE DUO
K140804 · Stereotaxis, Inc. · Sep 2014
MAGELLAN ROBOTIC SYSTEM
K141614 · Hansen Medical · Aug 2014
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369 · Hansen Medical, Inc. · Sep 2013
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
K122488 · Catheter Robotics, Inc. · Nov 2012
CORPATH 200 SYSTEM
K120834 · Corindus, Inc. · Jul 2012