Cleared Traditional

SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (K042734) - FDA 510(k) Clearance

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

K042734 · St. Jude Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
77d
Days
Class 2
Risk

K042734 is an FDA 510(k) clearance for the SJM RIGID SADDLE RING MODEL RSAR-(SIZE). Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all St. Jude Medical, Inc. devices

Submission Details

510(k) Number K042734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2004
Decision Date December 17, 2004
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 34
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K042734.
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
K083835 · St Jude Medical · Jan 2009
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · Medtronic, Inc. · Mar 2008
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · Edwards Lifesciences, LLC · Aug 2003
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · Edwards Lifesciences, LLC · Apr 2002
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · Medtronic Vascular · Jul 2001