Cleared Special

MEMO 4D (K180411) - FDA 510(k) Clearance

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

K180411 · Sorin Group Italia S.R.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
29d
Days
Class 2
Risk

K180411 is an FDA 510(k) clearance for the MEMO 4D. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Saluggia, IT). The FDA issued a Cleared decision on March 16, 2018 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 Sorin Group Italia S.R.L. devices

Submission Details

510(k) Number K180411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2018
Decision Date March 16, 2018
Days to Decision 29 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
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 33
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K180411.
Physio Flex Annuloplasty Ring
K192762 · Edwards Lifesciences, LLC · Dec 2019
NeoForm Annuloplasty Ring
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Tri-Ad 2.0 Adams Tricuspid Band
K181132 · Medtronic · May 2018
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
K103520 · Edwards Lifesciences, LLC · Jun 2011
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
K101212 · Medtronic, Inc. · Aug 2010
SJM ATTUNE ANNULOPLASTY RING
K092876 · St Jude Medical · Oct 2009