Cleared Traditional

NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 (K033685) - FDA 510(k) Clearance

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

K033685 · Medical Cv, Inc. · Cardiovascular device
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Aug 2004
Decision
253d
Days
Class 2
Risk

K033685 is an FDA 510(k) clearance for the NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Medical Cv, Inc. (Inver Grove Heights, US). The FDA issued a Cleared decision on August 3, 2004 after a review of 253 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3800 - 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 Medical Cv, Inc. devices

Submission Details

510(k) Number K033685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2003
Decision Date August 03, 2004
Days to Decision 253 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
128d slower than avg
Panel avg: 125d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRH Ring, Annuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3800
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.

Regulatory Peers - KRH Ring, Annuloplasty

All 73
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