Cleared Traditional

exGraft, exGraft Carbon (K221628) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221628 · Peca Labs · Cardiovascular device
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Aug 2022
Decision
59d
Days
Class 2
Risk

K221628 is an FDA 510(k) clearance for the exGraft, exGraft Carbon. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Peca Labs (Pittsburgh, US). The FDA issued a Cleared decision on August 4, 2022 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 Peca Labs devices

Submission Details

510(k) Number K221628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date August 04, 2022
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 57
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K221628.
GORE® ACUSEAL Vascular Graft
K233551 · W.L. Gore & Associates, Inc. · Dec 2023
GORE® ACUSEAL Vascular Graft
K231505 · W.L. Gore & Associates, Inc. · Jun 2023
HeRO Graft
K213845 · Merit Medical Systems, Inc. · Aug 2022
HeRO Graft, HeRO Adapter
K203724 · Merit Medical Systems, Inc. · May 2021
Vascutek Gelsoft Plus ERS Vascular Graft
K202703 · Vascutek, Ltd. · Apr 2021
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
K202471 · Peca Labs · Dec 2020