Cleared Traditional

K053188 - REPROCESSED BALOON INFLATION DEVICE

K053188 is an FDA 510(k) clearance for REPROCESSED BALOON INFLATION DEVICE, manufactured by Sterilmed, Inc.. The device is a Class 2 Cardiovascular device with product code NKU cleared through the Traditional 510(k) pathway after a 170-day FDA review.

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

FDA 510(k) Submission Details - K053188

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
Combination Product No
PCCP Authorized No
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.

NKU Device Classification - Class 2, Special Controls

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.