Cleared Traditional

K080813 - PRESSUREWIRE CERTUS

K080813 is an FDA 510(k) clearance for PRESSUREWIRE CERTUS, manufactured by Radi Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K080813 · Radi Medical Systems AB · Cardiovascular device
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Jul 2008
Decision
102d
Days
Class 2
Risk

K080813 is an FDA 510(k) clearance for the PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER. 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 July 1, 2008 after a review of 102 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K080813

510(k) Number K080813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2008
Decision Date July 01, 2008
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K080813.
TruWave Disposable Pressure Transducer
K142749 · Edwards Lifesciences, LLC · Jan 2015
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · Edwards Lifesciences, LLC · Sep 2014
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · St Jude Medical · Mar 2012
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