Cleared Traditional

SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M (K961246) - 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
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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 34
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K961246.
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
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · Medtronic Vascular · Jan 1999
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
K926138 · Baxter Healthcare Corp · Jun 1993
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · Baxter Healthcare Corp · Jan 1993
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
K914972 · Baxter Healthcare Corp · Jan 1992