Cleared Traditional

K113584 - PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113584 · St Jude Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2012
Decision
88d
Days
Class 2
Risk

K113584 is an FDA 510(k) clearance for the PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by St Jude Medical (Westford, US). The FDA issued a Cleared decision on March 2, 2012 after a review of 88 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.

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Submission Details

510(k) Number K113584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date March 02, 2012
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.