# K113148: E-PASS

- Pathway: 510(k) (Traditional)
- Applicant: Synexmed (Shenzhen)Company Limited
- Decided: Feb 28, 2012 after 127 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854261 (1985). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042060: Easypass US Y-Connector Hemostatic Valve, Millimed A/S (2004) Summary page 1.

## Most influential descendants
- K153685: Sunmed Haemostatic Valves (2016), 0 descendants of its own

## Indications for use
The B-Pass is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French. The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter. The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

Source page: https://510kreport.com/device/K113148
Methodology: https://510kreport.com/methodology