# K092711: Guardian II Hemostasis Valve

- Pathway: 510(k) (Special)
- Applicant: Zerusa Limited
- Decided: Oct 1, 2009 after 28 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K854261 (1985). 5 ancestors in all.
8 later devices descend from it; 3 cite it directly.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052381: Guardian Hemostasis Valve with Guidewire Introducer, Zerusa Limited (2005) Summary page 1.
- K073620: Guardian Hemostasis Valve, Zerusa Limited (2008) Summary page 1.

## Most influential descendants
- 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
- K122301: Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve (2012), 1 descendant of its own
- K221917: Stent Positioning Assistance System (SPAS) (2022), 0 descendants of its own

## Recalls of this device
- Feb 27, 2013 · Class I · Z-0955-2013: Risk that air may be introduced into the device which may lead to an air embolism.
- Aug 30, 2012 · Class II · Z-2400-2012: Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of pro

## Indications for use
The Guardian TM II 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.OF (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian TM II HV. The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.

Source page: https://510kreport.com/device/K092711
Methodology: https://510kreport.com/methodology