Cleared Traditional

K012574 - REPROCESSED FEMORAL COMPRESSION DEVICE

K012574 is an FDA 510(k) clearance for REPROCESSED FEMORAL COMPRESSION DEVICE, manufactured by Sterilmed, Inc.. The device is a Class 2 Cardiovascular device with product code NMF cleared through the Traditional 510(k) pathway after a 343-day FDA review.

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

FDA 510(k) Submission Details - K012574

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
Combination Product No
PCCP Authorized No
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.

NMF Device Classification - Class 2, Special Controls

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.