Cleared Traditional

K961246 - SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M (FDA 510(k) Clearance)

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

K961246 · St. Jude Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
319d
Days
Class 2
Risk

K961246 is an FDA 510(k) clearance for the SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M. 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 February 14, 1997 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 St. Jude Medical, Inc. devices

Submission Details

510(k) Number K961246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received April 01, 1996
Decision Date February 14, 1997
Days to Decision 319 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 125d · This submission: 319d
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
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K961246.
TriMemo™ SEMIRIGID ANNULOPLASTY RING
K260498 · Corcym S.r.l. · Apr 2026
Seguin Annuloplasty Ring
K253232 · Abbott Medical · Oct 2025
Edwards MC3 Tricuspid annuloplasty ring (4900)
K251982 · Edwards Lifesciences, LLC · Sep 2025
Carpentier-Edwards Physio Annuloplasty Ring (4450)
K251688 · Edwards Lifesciences, LLC · Sep 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K250859 · Genesee Biomedical, Inc. · Jul 2025
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K232599 · Genesee Biomedical, Inc. · Apr 2024