Cleared Traditional

K033685 - NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000

K033685 is an FDA 510(k) clearance for NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, manufactured by Medical Cv, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K033685 · Medical Cv, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K033685

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.

KRH Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K033685.
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · Medtronic, Inc. · Mar 2008
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
K042734 · St. Jude Medical, Inc. · Dec 2004
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · Edwards Lifesciences, LLC · Aug 2003
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · St. Jude Medical, Inc. · Sep 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · Edwards Lifesciences, LLC · Apr 2002