Cleared Special

K253232 - Seguin Annuloplasty Ring

K253232 is an FDA 510(k) clearance for Seguin Annuloplasty Ring, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Special 510(k) pathway after a 30-day FDA review.

K253232 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
30d
Days
Class 2
Risk

K253232 is an FDA 510(k) clearance for the Seguin Annuloplasty Ring. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Abbott Medical (St. Paul, US). The FDA issued a Cleared decision on October 29, 2025 after a review of 30 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.

FDA 510(k) Submission Details - K253232

510(k) Number K253232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date October 29, 2025
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 73
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K253232.
MEMO 4D Curve™ Semirigid mitral annuloplasty ring
K261707 · Corcym S.r.l. · Jun 2026
TriMemo™ SEMIRIGID ANNULOPLASTY RING
K260498 · Corcym S.r.l. · Apr 2026
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
K253232 · Seguin Annuloplasty Ring
Download PDF FDA Summary Abbott Medical