Cleared Special

SEGUIN ANNULOPLASTY RING (K092310) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092310 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
29d
Days
Class 2
Risk

K092310 is an FDA 510(k) clearance for the SEGUIN ANNULOPLASTY RING. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by St Jude Medical (St.Paul, US). The FDA issued a Cleared decision on August 27, 2009 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all St Jude Medical devices

Submission Details

510(k) Number K092310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date August 27, 2009
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 23
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K092310.
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · Medtronic · May 2018
MEMO 4D
K180411 · Sorin Group Italia S.R.L. · Mar 2018
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · Medtronic, Inc. · Aug 2010
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · Medtronic, Inc. · Mar 2008
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · Medtronic Vascular · Jul 2001