510(k) · Cleared
Recalled · 2006Advanced Cardiovascular Systems Hemostatic Valves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Cardiovascular Systems, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Dec 4, 1985 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 38 devices in its family, counting itself, have a Class I recall. 37 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 4, 1985
- Review
- 42 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 2
- Predicates
- 0
37 later devices descend from it, 2 citing it directly. 3 of the 38 devices in this family, counting this one, have a Class I recall.
- This deviceK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985
- Descendant · cites it directly · 34 of its ownK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- Descendant · 2 generations on · 17 of its ownK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- Descendant · 2 generations on · 12 of its ownK040498 MyshellSedat S.A. · 2004
- Descendant · 2 generations on · 11 of its ownK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
- Descendant · 3 generations on · 10 of its ownK073620 Guardian Hemostasis ValveZerusa Limited · 2008
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 37 · See all- K991102Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · cites it directly34descendants
- K042060Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004 · 2 generations on17descendants
- K040498MyshellSedat S.A. · 2004 · 2 generations on12descendants
- K052381Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005 · 2 generations on11descendants
- K073620Guardian Hemostasis ValveZerusa Limited · 2008 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | — |
| +1 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| +2 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| +2 | K040498 | Myshell | Sedat S.A. | 2004 | — |
| +2 | K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | 2005 | — |
| +3 | K073620 | Guardian Hemostasis Valve | Zerusa Limited | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 1 |
| 2010 | 4 | 1 |
| 2012 | 4 | 1 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (37)
See all 372 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 |
|---|---|---|---|---|
| Dec 5, 2006 | Not classified | Z-0390-2007 | Other | Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch |
| Dec 5, 2006 | Not classified | Z-0391-2007 | Other | Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch |
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 · 3 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 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K101113Guardian II NC Hemostasis ValveZerusa Limited · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K991102 (Guidant Corp., 1999) has gone furthest, with 34 descendants of its own.
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) | — |
https://510kreport.com/device/K854261 · printed Nov 5, 2026
Cite this page
510(k) Report. “K854261: Advanced Cardiovascular Systems Hemostatic Valves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K854261
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026