Cleared Traditional

K042734 - SJM RIGID SADDLE RING MODEL RSAR-(SIZE)

K042734 is an FDA 510(k) clearance for SJM RIGID SADDLE RING MODEL RSAR-(SIZE), manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K042734 · St. Jude Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K042734

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
Combination Product No
PCCP Authorized No
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.

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 69
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K042734.
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
K052565 · Genesee Biomedical, Inc. · Nov 2005
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
K052899 · Genesee Biomedical, Inc. · Nov 2005
CG FUTURE ANNULOPLASTY BAND
K052860 · Medtronic Heart Valves · Nov 2005
NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
K033685 · Medical Cv, Inc. · Aug 2004
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
K032810 · Medtronic Heart Valves · Dec 2003
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · Edwards Lifesciences, LLC · Aug 2003