Cleared Traditional

K190049 - Sim&Size (FDA 510(k) Clearance)

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

K190049 · Sim&Cure · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
250d
Days
Class 2
Risk

K190049 is an FDA 510(k) clearance for the Sim&Size. Classified as Software For Visualization Of Vascular Anatomy And Intravascular Devices (product code PZO), Class II - Special Controls.

Submitted by Sim&Cure (Grabels, FR). The FDA issued a Cleared decision on September 17, 2019 after a review of 250 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.2050 - 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 Sim&Cure devices

Submission Details

510(k) Number K190049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2019
Decision Date September 17, 2019
Days to Decision 250 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
125d slower than avg
Panel avg: 125d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning.
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 - PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices

All 9
Devices cleared under the same product code (PZO) and FDA review panel - the closest regulatory comparables to K190049.
Sim&Size
K253122 · Sim&Cure · Dec 2025
ANKYRAS
K250160 · Mentice Spain S.L. · May 2025
Sim&Size
K242124 · Sim&Cure · Dec 2024
Ankyras
K230006 · Mentice Spain S.L. · Dec 2023
Sim&Size
K222664 · Sim&Cure · Jan 2023
AneuGuide
K213838 · ArteryFlow Technology Co., Ltd. · Jun 2022