Cleared Traditional

K053188 - REPROCESSED BALOON INFLATION DEVICE (FDA 510(k) Clearance)

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

K053188 · Sterilmed, Inc. · Cardiovascular device
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May 2006
Decision
170d
Days
Class 2
Risk

K053188 is an FDA 510(k) clearance for the REPROCESSED BALOON INFLATION DEVICE. Classified as Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed (product code NKU), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on May 4, 2006 after a review of 170 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K053188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2005
Decision Date May 04, 2006
Days to Decision 170 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
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKU Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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.