Cleared Traditional

K022187 - PRESSURE WIRE SENSOR

K022187 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 Traditional 510(k) pathway after a 81-day FDA review.

K022187 · Radi Medical Systems AB · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2002
Decision
81d
Days
Class 2
Risk

K022187 is an FDA 510(k) clearance for the PRESSURE WIRE SENSOR, MODELS 12003/12303, 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 September 24, 2002 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radi Medical Systems AB devices

FDA 510(k) Submission Details - K022187

510(k) Number K022187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2002
Decision Date September 24, 2002
Days to Decision 81 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
44d faster than avg
Panel avg: 125d · This submission: 81d
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 K022187.
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 12004/12304
K031662 · Radi Medical Systems AB · Jun 2003
INNERSENSE DISPOSABLE MICROTRANSDUCER
K941283 · Becton Dickinson Vascular Access, Inc. · Apr 1994
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · Baxter Healthcare Corp · Oct 1993
INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER
K924737 · Becton Dickinson Vascular Access, Inc. · Aug 1993