Cleared Special

K253616 - ProtekDilate Vascular Access Kit (FDA 510(k) Clearance)

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

K253616 · Sorin Group Italia S.R.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
31d
Days
Class 2
Risk

K253616 is an FDA 510(k) clearance for the ProtekDilate Vascular Access Kit. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola ( Modena), IT). The FDA issued a Cleared decision on December 19, 2025 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 K253616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2025
Decision Date December 19, 2025
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 Consultant

LivaNova USA, Inc.
Jennifer Houck

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRE Dilator, Vessel, For Percutaneous Catheterization

All 103
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K253616.
VersaCross Connect™ Transseptal Dilator
K251325 · Baylis Medical Company, Inc. · May 2025
Micro Ace Gold Advanced Micro Access System
K242229 · Merit Medical Systems, Inc. · Jan 2025
VersaCross Connect™ Transseptal Dilator
K241720 · Baylis Medical Company, Inc. · Jul 2024
VersaCross Connect™ Transseptal Dilator
K233647 · Baylis Medical Company, Inc. · Dec 2023
Micro Ace™ Advanced Micro Access System
K232609 · Merit Medical Systems, Inc. · Sep 2023
Endovascular Dilator and Sets
K210734 · Cook Incorporated · Apr 2021