Cleared Traditional

Physio Flex Annuloplasty Ring (K192762) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192762 · Edwards Lifesciences, LLC · Cardiovascular device
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Dec 2019
Decision
77d
Days
Class 2
Risk

K192762 is an FDA 510(k) clearance for the Physio Flex Annuloplasty Ring. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 16, 2019 after a review of 77 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.

View all Edwards Lifesciences, LLC devices

Submission Details

510(k) Number K192762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date December 16, 2019
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 30
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K192762.
Memo 3D Semirigid Annuloplasty Ring
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TruForm Sievers Annuloplasty Ring
K202253 · Genesee Biomedical, Inc. · Oct 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
K201449 · Medtronic, Inc. · Jul 2020
NeoForm Annuloplasty Ring
K190506 · Genesee Biomedical, Inc. · Apr 2019
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · Medtronic · May 2018
MEMO 4D
K180411 · Sorin Group Italia S.R.L. · Mar 2018