Cleared Traditional

K012574 - REPROCESSED FEMORAL COMPRESSION DEVICE (FDA 510(k) Clearance)

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

K012574 · Sterilmed, Inc. · Cardiovascular device
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Jul 2002
Decision
343d
Days
Class 2
Risk

K012574 is an FDA 510(k) clearance for the REPROCESSED FEMORAL COMPRESSION DEVICE. Classified as Clamp, Vascular, Reprocessed (product code NMF), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 18, 2002 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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. Elevated predicate reliance profile. 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 K012574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2001
Decision Date July 18, 2002
Days to Decision 343 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
218d slower than avg
Panel avg: 125d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NMF Clamp, Vascular, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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.