Cleared Special

Sterile Dilator (K192195) - FDA 510(k) Clearance

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

K192195 · Galt Medical Corp. · Cardiovascular device
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Sep 2019
Decision
44d
Days
Class 2
Risk

K192195 is an FDA 510(k) clearance for the Sterile Dilator. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on September 26, 2019 after a review of 44 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 Galt Medical Corp. devices

Submission Details

510(k) Number K192195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2019
Decision Date September 26, 2019
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
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 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 K192195.
ProtekDilate Vascular Access Kit
K253616 · Sorin Group Italia S.R.L. · Dec 2025
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