Cleared Traditional

K242520 - Element Vascular Access System

K242520 is the FDA 510(k) clearance for Element Vascular Access System by Penumbra, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K242520 · Penumbra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
89d
Days
Class 2
Risk

K242520 is an FDA 510(k) clearance for the Element Vascular Access System. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on November 20, 2024 after a review of 89 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 Penumbra, Inc. devices

Submission Details

510(k) Number K242520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2024
Decision Date November 20, 2024
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K242520.
iSLEEVE Introducer Set
K250468 · Boston Scientific · Mar 2025
Catapult Guide Sheath
K250439 · Contract Medical International, GmbH · Mar 2025
Agilis NxT Steerable Introducer Dual-Reach
K243493 · Abbott Medical · Dec 2024
Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
K242756 · Pulnovo Medical (Wuxi) Co., Ltd. · Nov 2024
SonoStik Guide Wire Introducer
K243061 · Sonostik, LLC · Nov 2024
AuST Steerable Sheath
K242106 · CenterPoint Systems, LLC · Oct 2024