Cleared Special

K021051 - ANNULOFLO SYSTEM, MITRAL MODEL AR700

K021051 is an FDA 510(k) clearance for ANNULOFLO SYSTEM, manufactured by Sulzer Carbomedics, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Special 510(k) pathway after a 22-day FDA review.

K021051 · Sulzer Carbomedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
22d
Days
Class 2
Risk

K021051 is an FDA 510(k) clearance for the ANNULOFLO SYSTEM, MITRAL MODEL AR700. 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 April 23, 2002 after a review of 22 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 - K021051

510(k) Number K021051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date April 23, 2002
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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 71
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K021051.
SHELHIGH BIORING
K023940 · Shelhigh, Inc. · Jun 2003
ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
K023185 · Sulzer Carbomedics, Inc. · Dec 2002
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · St. Jude Medical, Inc. · Sep 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · Edwards Lifesciences, LLC · Apr 2002
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
K014161 · St. Jude Medical, Inc. · Jan 2002
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
K014037 · St. Jude Medical, Inc. · Jan 2002
K021051 · ANNULOFLO SYSTEM, MITRAL MODEL AR700
Download PDF FDA Summary Sulzer Carbomedics, I…