Cleared Traditional

K212152 - Prelude IDeal 9F Hydrophilic Sheath Int...

K212152 is an FDA 510(k) clearance for Prelude IDeal 9F Hydrophilic Sheath Int..., manufactured by Merit Medical Systems. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K212152 · Merit Medical Systems · Cardiovascular device
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Jan 2022
Decision
182d
Days
Class 2
Risk

K212152 is an FDA 510(k) clearance for the Prelude IDeal 9F Hydrophilic Sheath Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Merit Medical Systems (South Jordan, US). The FDA issued a Cleared decision on January 7, 2022 after a review of 182 days - an extended review 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: 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 Merit Medical Systems devices

FDA 510(k) Submission Details - K212152

510(k) Number K212152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2021
Decision Date January 07, 2022
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 461
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K212152.
PathBuilder Transseptal Guiding Introducer
K212626 · Shanghai Microport EP Medtech Co., Ltd. · Mar 2022
PathBuilder Steerable Introducer
K211530 · Shanghai Microport EP Medtech Co., Ltd. · Feb 2022
AcQCross Qx Integrated Transseptal Dilator/Needle
K220047 · Acutus Medical, Inc. · Feb 2022
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
K213638 · Argon Medical Devices · Dec 2021
SCORPION Portal Vein Access Set
K213002 · Argon Medical Devices · Oct 2021
Prelude Guide Sheath
K211405 · Merit Medical Systems, Inc. · Oct 2021