Cleared Traditional

K252508 - Intri26 Introducer Sheath

K252508 is an FDA 510(k) clearance for Intri26 Introducer Sheath, manufactured by Inari Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K252508 · Inari Medical, Inc. · Cardiovascular device
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Dec 2025
Decision
131d
Days
Class 2
Risk

K252508 is an FDA 510(k) clearance for the Intri26 Introducer Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on December 17, 2025 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Inari Medical, Inc. devices

FDA 510(k) Submission Details - K252508

510(k) Number K252508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2025
Decision Date December 17, 2025
Days to Decision 131 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
6d slower than avg
Panel avg: 125d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 596
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K252508.
AuST CSP Introducer
K260163 · CenterPoint Systems, LLC · Feb 2026
Peel-Away Introducer Sheath
K254236 · VascuTech Medical, LLC · Feb 2026
Genie MAX Large Bore Introducer Sheath
K253652 · Cultiv8 1, LLC · Jan 2026
V•Stick™ Vascular Access Set
K253741 · Argon Medical Devices, Inc. · Dec 2025
PerQseal Introducers
K252309 · Vivasure Medical Limited · Oct 2025
Introducer Sheath Set
K251838 · Cardiocycle Medical(Suzhou) Co., Ltd. · Oct 2025