# K052381: Guardian Hemostasis Valve with Guidewire Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Zerusa Limited
- Decided: Nov 21, 2005 after 83 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.
11 later devices descend from it; 2 cite it directly.
3 of 15 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.
- K042060: Easypass US Y-Connector Hemostatic Valve, Millimed A/S (2004) Summary page 1.

## Most influential descendants
- 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
- K170684: Firebow Wire Torque Assist Device (2017), 1 descendant of its own

## Indications for use
The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV.

Source page: https://510kreport.com/device/K052381
Methodology: https://510kreport.com/methodology