# K142245: EpiAccess System

- Pathway: 510(k) (Traditional)
- Applicant: Epiep, Inc.
- Decided: Oct 29, 2014 after 77 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K831506 (1983). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111943: Agills PF Delivery System, St. Jude Medical, Cardiac Rhythm Management Divisi (2011) Summary page 4.
- K112203: Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist, Arterial Assist, Mirador Biomedical, Inc. (2011) Summary page 4.

## Most influential descendants
- K170831: EpiAccess System (2017), 0 descendants of its own

## Indications for use
The EpiAccess System with introducer needle and integrated needle tip pressure transducer is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in electrophysiology procedures in adult patients.

Source page: https://510kreport.com/device/K142245
Methodology: https://510kreport.com/methodology