Cleared Traditional

REPROCESSED IMAGING CATHETERS (K012537) - FDA 510(k) Clearance

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

K012537 · Sterilmed, Inc. · Cardiovascular device
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Oct 2002
Decision
430d
Days
Class 2
Risk

K012537 is an FDA 510(k) clearance for the REPROCESSED IMAGING CATHETERS. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on October 11, 2002 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Sterilmed, Inc. devices

Submission Details

510(k) Number K012537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date October 11, 2002
Days to Decision 430 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
305d slower than avg
Panel avg: 125d · This submission: 430d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWQ Reprocessed Intravascular Ultrasound Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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.