Cleared Traditional

K253122 - Sim&Size (FDA 510(k) Clearance)

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

K253122 · Sim&Cure · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2025
Decision
89d
Days
Class 2
Risk

K253122 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 (Montpellier, FR). The FDA issued a Cleared decision on December 23, 2025 after a review of 89 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K253122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2025
Decision Date December 23, 2025
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
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 Neurology 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 K253122.
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K213838 · ArteryFlow Technology Co., Ltd. · Jun 2022
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K212373 · Sim&Cure · Jan 2022