Cleared Traditional

K023185 - ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800

K023185 is an FDA 510(k) clearance for ANNULOFLEX ANNUOPLASTY SYSTEM, manufactured by Sulzer Carbomedics, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K023185 · Sulzer Carbomedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
84d
Days
Class 2
Risk

K023185 is an FDA 510(k) clearance for the ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Sulzer Carbomedics, Inc. (Austin, US). The FDA issued a Cleared decision on December 17, 2002 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023185

510(k) Number K023185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2002
Decision Date December 17, 2002
Days to Decision 84 days
Submission Type Traditional
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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 71
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K023185.
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
K032810 · Medtronic Heart Valves · Dec 2003
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · Edwards Lifesciences, LLC · Aug 2003
SHELHIGH BIORING
K023940 · Shelhigh, Inc. · Jun 2003
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · St. Jude Medical, Inc. · Sep 2002
ANNULOFLO SYSTEM, MITRAL MODEL AR700
K021051 · Sulzer Carbomedics, Inc. · Apr 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · Edwards Lifesciences, LLC · Apr 2002
K023185 · ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
Download PDF FDA Summary Sulzer Carbomedics, I…