510(k) · Cleared
ClearedGuardian Hemostasis Valve with Guidewire Introducer
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 Nov 21, 2005 as substantially equivalent to K991102 (Guidant Corp., 1999) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1985. 3 of the 15 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Nov 21, 2005
- Review
- 83 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K854261 (1985). 11 later devices descend from it, 2 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 2 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 1 generation backK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- This deviceK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
- Descendant · cites it directly · 10 of its ownK073620 Guardian Hemostasis ValveZerusa Limited · 2008
- Descendant · cites it directly · 8 of its ownK092711 Guardian II Hemostasis ValveZerusa Limited · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK100093 Vsi Torque DeviceVascular Solutions, Inc. · 2010
- Descendant · 3 generations on · 3 of its ownK141054 Distal Access Torque DeviceDistal Access, LLC · 2014
- Descendant · 4 generations on · 1 of its ownK170684 Firebow Wire Torque Assist DeviceVesatek, LLC · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K073620Guardian Hemostasis ValveZerusa Limited · 2008 · cites it directly10descendants
- K092711Guardian II Hemostasis ValveZerusa Limited · 2009 · cites it directly8descendants
- K100093Vsi Torque DeviceVascular Solutions, Inc. · 2010 · 2 generations on4descendants
- K141054Distal Access Torque DeviceDistal Access, LLC · 2014 · 3 generations on3descendants
- K170684Firebow Wire Torque Assist DeviceVesatek, LLC · 2017 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −2 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −1 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| 0 (this device) | K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | 2005 | — |
| +1 | K073620 | Guardian Hemostasis Valve | Zerusa Limited | 2008 | — |
| +1 | K092711 | Guardian II Hemostasis Valve | Zerusa Limited | 2009 | Class I |
| +2 | K100093 | Vsi Torque Device | Vascular Solutions, Inc. | 2010 | — |
| +3 | K141054 | Distal Access Torque Device | Distal Access, LLC | 2014 | — |
| +4 | K170684 | Firebow Wire Torque Assist Device | Vesatek, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 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 |
|---|---|---|---|
| * | K991102 | Copilot Bleedback Control Valve, Model 1003331Summary page 1…vices used to determine substantial equivalence for the Zerusa Limited Guardian Hemostasis Valve were the CoPilot Bleedback Control Valve marketed by Guidant (#K991102) and the EasyPass Y-connector Hemostatic Valve marketed by Millimed A/S (#K042060). 4. DEVICE DESCRIPTION: The Zer… | 1999 |
| * | K042060 | Easypass US Y-Connector Hemostatic ValveSummary page 1…mostasis Valve were the CoPilot Bleedback Control Valve marketed by Guidant (#K991102) and the EasyPass Y-connector Hemostatic Valve marketed by Millimed A/S (#K042060). 4. DEVICE DESCRIPTION: The Zerusa GuardianTM Hemostasis Valve is designed to be used as a conduit for which inte… | 2004 |
What descends from it? (11)
See all 112 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)
No FDA recall names this device.
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.
- K092711Guardian II Hemostasis ValveZerusa Limited · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K101113Guardian II NC Hemostasis ValveZerusa Limited · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K073620 (Zerusa Limited, 2008) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K991102.
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.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052381: Guardian Hemostasis Valve with Guidewire Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052381
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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