510(k) · Cleared
ClearedEasypass US Y-Connector Hemostatic Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millimed A/S · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Oct 6, 2004 as substantially equivalent to K991102 (Guidant Corp., 1999) after a 68-day review. Its family tree reaches back 2 generations to 1985. 3 of the 20 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.
- Decided
- Oct 6, 2004
- Review
- 68 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854261 (1985). 17 later devices descend from it, 4 citing it directly. 3 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 1 generation backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- This deviceK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- Descendant · cites it directly · 11 of its ownK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
- Descendant · 2 generations on · 10 of its ownK073620 Guardian Hemostasis ValveZerusa Limited · 2008
- Descendant · 2 generations on · 8 of its ownK092711 Guardian II Hemostasis ValveZerusa Limited · 2009 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK100093 Vsi Torque DeviceVascular Solutions, Inc. · 2010
- Descendant · 4 generations on · 3 of its ownK141054 Distal Access Torque DeviceDistal Access, LLC · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 17 · See all- K052381Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005 · cites it directly11descendants
- K073620Guardian Hemostasis ValveZerusa Limited · 2008 · 2 generations on10descendants
- K092711Guardian II Hemostasis ValveZerusa Limited · 2009 · 2 generations on8descendants
- K100093Vsi Torque DeviceVascular Solutions, Inc. · 2010 · 3 generations on4descendants
- K141054Distal Access Torque DeviceDistal Access, LLC · 2014 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −1 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| 0 (this device) | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| +1 | K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | 2005 | — |
| +2 | K073620 | Guardian Hemostasis Valve | Zerusa Limited | 2008 | — |
| +2 | K092711 | Guardian II Hemostasis Valve | Zerusa Limited | 2009 | Class I |
| +3 | K100093 | Vsi Torque Device | Vascular Solutions, Inc. | 2010 | — |
| +4 | K141054 | Distal Access Torque Device | Distal Access, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 1 |
| 2010 | 2 | 1 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (1)
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…II Summary of Substantial Equivalence: The EasyPass Y-connector Hemostatic Valve is substantially equivalent to Guidant Corporation's Copilot Bleedback Control Valve (K991 102) Device Description: The EasyPasSTM US Y-connector Hemostatic Valve consists of a y-connector body with a rotating luer lock, a… | 1999 |
What descends from it? (17)
See all 174 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 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K101113Guardian II NC Hemostasis ValveZerusa Limited · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K052381 (Zerusa Limited, 2005) has gone furthest, with 11 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042060: Easypass US Y-Connector Hemostatic Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042060
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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