Cleared Traditional

K961246 - SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M

K961246 is an FDA 510(k) clearance for SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M, 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 319-day FDA review.

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

FDA 510(k) Submission Details - K961246

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
Combination Product No
PCCP Authorized No
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.

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 44
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K961246.
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
K000119 · St. Jude Medical, Inc. · Feb 2000
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · Medtronic Vascular · Jan 1999
ANNULOFLO SYSTEM
K970375 · Carbomedics, Inc. · Jul 1997
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