Cleared Traditional

K251838 - Introducer Sheath Set

K251838 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 127-day FDA review.

K251838 · Cardiocycle Medical(Suzhou) Co., Ltd. · Cardiovascular device
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Oct 2025
Decision
127d
Days
Class 2
Risk

K251838 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 October 21, 2025 after a review of 127 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 - K251838

510(k) Number K251838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2025
Decision Date October 21, 2025
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 438
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K251838.
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