Cleared Traditional

K172099 - Shoocin Introducer Kit

K172099 is an FDA 510(k) clearance for Shoocin Introducer Kit, manufactured by Lepu Medical Technology (Beijing) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K172099 · Lepu Medical Technology (Beijing) Co., Ltd. · Cardiovascular device
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Oct 2017
Decision
86d
Days
Class 2
Risk

K172099 is an FDA 510(k) clearance for the Shoocin Introducer Kit. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Lepu Medical Technology (Beijing) Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on October 5, 2017 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lepu Medical Technology (Beijing) Co., Ltd. devices

FDA 510(k) Submission Details - K172099

510(k) Number K172099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2017
Decision Date October 05, 2017
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
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 462
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K172099.
Peel-Away Introducer Set
K173685 · Cook Incorporated · Dec 2017
Performer Introducer
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D'Vill Introducer
K171206 · NuMED, Inc. · Oct 2017
Peel-Away Introducer Set
K170020 · Cook Incorporated · Sep 2017
Prelude Pursuit Splittable Sheath Introducer
K172117 · Merit Medical Systems, Inc. · Sep 2017
Liver Access and Biopsy Sets
K171853 · Cook Incorporated · Aug 2017