Cleared Traditional

K142245 - EpiAccess System

K142245 is an FDA 510(k) clearance for EpiAccess System, manufactured by Epiep, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K142245 · Epiep, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
77d
Days
Class 2
Risk

K142245 is an FDA 510(k) clearance for the EpiAccess System. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Epiep, Inc. (New Haven, US). The FDA issued a Cleared decision on October 29, 2014 after a review of 77 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.

FDA 510(k) Submission Details - K142245

510(k) Number K142245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2014
Decision Date October 29, 2014
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Cygnus Regulatory
Elsa Abruzzo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02209064 Completed Interventional Industry-sponsored

"EASE" Epicardial Access With the EpiAccess System

EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.

25
Patients (actual)
1
Site
Supportive_care
Purpose
Open label
Masking
Condition studied Arrhythmias, Cardiac
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Andrea Natale, MD
Sponsor EpiEP, Inc. (industry)
Started 2013-12-01 → Primary completion 2015-03-01 → Completed 2015-11-01
Primary outcome
Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
Secondary outcome
Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System
View full study on ClinicalTrials.gov

Regulatory Peers - DYB Introducer, Catheter

All 662
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K142245.
TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
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