Cleared Special

K031662 - PRESSURE WIRE SENSOR

K031662 is an FDA 510(k) clearance for PRESSURE WIRE SENSOR, manufactured by Radi Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Special 510(k) pathway after a 9-day FDA review.

K031662 · Radi Medical Systems AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
9d
Days
Class 2
Risk

K031662 is an FDA 510(k) clearance for the PRESSURE WIRE SENSOR, MODELS 12004/12304. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on June 6, 2003 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 Radi Medical Systems AB devices

FDA 510(k) Submission Details - K031662

510(k) Number K031662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2003
Decision Date June 06, 2003
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 33
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K031662.
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
K070487 · Volcano Corporation · Mar 2007
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
K062769 · Radi Medical Systems AB · Dec 2006
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
K053016 · Edwards Lifesciences, LLC · Dec 2005
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · Radi Medical Systems AB · Sep 2002
INNERSENSE DISPOSABLE MICROTRANSDUCER
K941283 · Becton Dickinson Vascular Access, Inc. · Apr 1994
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · Baxter Healthcare Corp · Oct 1993