Cleared Traditional

K254248 - Introducer Sheath Set

K254248 is an FDA 510(k) clearance for Introducer Sheath Set, manufactured by Cardiocycle Medical(Suzhou) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K254248 · Cardiocycle Medical(Suzhou) Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
115d
Days
Class 2
Risk

K254248 is an FDA 510(k) clearance for the Introducer Sheath Set. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cardiocycle Medical(Suzhou) Co., Ltd. (Suzhou, Jiangsu, CN). The FDA issued a Cleared decision on April 23, 2026 after a review of 115 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 Cardiocycle Medical(Suzhou) Co., Ltd. devices

FDA 510(k) Submission Details - K254248

510(k) Number K254248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date April 23, 2026
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K254248.
Health Line Tearaway Introducer
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Echo Large Bore Introducer Sheath
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Edwards eSheath+ introducer set
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Aventus Introducer Sheath
K260091 · Inquis Medical · Apr 2026
Protaryx Transseptal Puncture Device (PTX2-001)
K260839 · Protaryx Medical, Inc. · Apr 2026