# K042060: Easypass US Y-Connector Hemostatic Valve

- Pathway: 510(k) (Traditional)
- Applicant: Millimed A/S
- Decided: Oct 6, 2004 after 68 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: 2 generations back to K854261 (1985). 2 ancestors in all.
17 later devices descend from it; 4 cite it directly.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991102: Copilot Bleedback Control Valve, Model 1003331, Guidant Corp. (1999) Summary page 1.

## Most influential descendants
- K052381: Guardian Hemostasis Valve with Guidewire Introducer (2005), 11 descendants of its own
- K073620: Guardian Hemostasis Valve (2008), 10 descendants of its own
- K092711: Guardian II Hemostasis Valve (2009), 8 descendants of its own
- K100093: Vsi Torque Device (2010), 4 descendants of its own
- K141054: Distal Access Torque Device (2014), 3 descendants of its own

## Indications for use
The EasyPass TM US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller. The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter. The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.

Source page: https://510kreport.com/device/K042060
Methodology: https://510kreport.com/methodology