510(k) · Cleared
Recalled · Class I · 2013Guardian II Hemostasis Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zerusa Limited · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Oct 1, 2009 as substantially equivalent to K052381 (Zerusa Limited, 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 1985. 3 of the 14 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Oct 1, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K854261 (1985). 8 later devices descend from it, 3 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 4 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 3 generations backK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- 2 generations backK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
- 1 generation backK073620 Guardian Hemostasis ValveZerusa Limited · 2008
- This deviceK092711 Guardian II Hemostasis ValveZerusa Limited · 2009
- Descendant · cites it directly · 4 of its ownK100093 Vsi Torque DeviceVascular Solutions, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK141054 Distal Access Torque DeviceDistal Access, LLC · 2014
- Descendant · 3 generations on · 1 of its ownK170684 Firebow Wire Torque Assist DeviceVesatek, LLC · 2017
- Descendant · cites it directly · 1 of its ownK122301 Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK221917 Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K100093Vsi Torque DeviceVascular Solutions, Inc. · 2010 · cites it directly4descendants
- K141054Distal Access Torque DeviceDistal Access, LLC · 2014 · 2 generations on3descendants
- K170684Firebow Wire Torque Assist DeviceVesatek, LLC · 2017 · 3 generations on1descendant
- K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 2012 · cites it directly1descendant
- K221917Stent Positioning Assistance System (SPAS)Seven Sons, Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −4 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −3 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| −2 | K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | 2005 | — |
| −1 | K073620 | Guardian Hemostasis Valve | Zerusa Limited | 2008 | — |
| 0 (this device) | K092711 | Guardian II Hemostasis Valve | Zerusa Limited | 2009 | — |
| +1 | K100093 | Vsi Torque Device | Vascular Solutions, Inc. | 2010 | — |
| +2 | K141054 | Distal Access Torque Device | Distal Access, LLC | 2014 | — |
| +3 | K170684 | Firebow Wire Torque Assist Device | Vesatek, LLC | 2017 | — |
| +1 | K122301 | Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve | Vascular Solutions Zerusa, Ltd. | 2012 | Class I |
| +3 | K221917 | Stent Positioning Assistance System (SPAS) | Seven Sons, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 1 |
| 2012 | 1 | 1 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052381 | Guardian Hemostasis Valve with Guidewire IntroducerSummary page 1…The predicate device used to determnine substantial equivalence for this device was the Zerusa Limited's currently marketed GuardianTm Hemostasis Valve (HK052381 and itK073620). 4. DEVICE DESCRIPTION: The Zerusa GuardianTM II Hemostasis Valve is designed to be used a… | 2005 |
| * | K073620 | Guardian Hemostasis ValveSummary page 1…e device used to determnine substantial equivalence for this device was the Zerusa Limited's currently marketed GuardianTm Hemostasis Valve (HK052381 and itK073620). 4. DEVICE DESCRIPTION: The Zerusa GuardianTM II Hemostasis Valve is designed to be used as a conduit… | 2008 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2013 | Class I | Z-0955-2013 | Vendor change control | Risk that air may be introduced into the device which may lead to an air embolism. |
| Aug 30, 2012 | Class II | Z-2400-2012 | Process control | 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 product contamination. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K101113Guardian II NC Hemostasis ValveZerusa Limited · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K100093 (Vascular Solutions, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K052381.
How does its category compare?
All DTL devicesDTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DTL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTL
36in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTL
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DTL
110in 2025
MAUDE reports naming product code DTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 37 |
| 2008 | 5 | 85 | 1 | 16 |
| 2009 | 2 | — | 0 | 62 |
| 2010 | 4 | 115 | 3 | 148 |
| 2011 | 0 | — | 1 | 160 |
| 2012 | 8 | 36 | 2 | 53 |
| 2013 | 1 | — | 1 (1) | 67 |
| 2014 | 2 | — | 1 | 80 |
| 2015 | 1 | — | 0 | 89 |
| 2016 | 0 | — | 0 | 67 |
| 2017 | 0 | — | 2 | 106 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 2 | 48 |
| 2023 | 0 | — | 0 | 46 |
| 2024 | 0 | — | 0 | 452 |
| 2025 | 0 | — | 1 | 110 |
| 2026 | 0 | — | 3 (3) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092711: Guardian II Hemostasis Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092711
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026