Cleared Traditional

K992056 - ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

K992056 is an FDA 510(k) clearance for ANNULOFLEX ANNULOPLASTY 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 116-day FDA review.

K992056 · Sulzer Carbomedics, Inc. · Cardiovascular device
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Oct 1999
Decision
116d
Days
Class 2
Risk

K992056 is an FDA 510(k) clearance for the ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800. 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 October 12, 1999 after a review of 116 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Sulzer Carbomedics, Inc. devices

FDA 510(k) Submission Details - K992056

510(k) Number K992056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1999
Decision Date October 12, 1999
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 49
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K992056.
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
K014037 · St. Jude Medical, Inc. · Jan 2002
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · Medtronic Vascular · Jul 2001
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
K000119 · St. Jude Medical, Inc. · Feb 2000
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · Medtronic Vascular · Jan 1999
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM
K980487 · Baxter Edwards · Jul 1998
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
K980534 · The Heart Valve Div. Medtronic Cardiovascular Surg · Apr 1998