510(k) · Cleared
Recalled · 2011Copilot Bleedback Control Valve, Model 1003331
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Jun 9, 1999 as substantially equivalent to K854261 (Advanced Cardiovascular Systems, Inc., 1985) after a 69-day review. Its family tree reaches back 1 generation to 1985. 3 of the 36 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it. It has been recalled once.
- Decided
- Jun 9, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- DTL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854261 (1985). 34 later devices descend from it, 7 citing it directly. 3 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- This deviceK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999
- Descendant · cites it directly · 17 of its ownK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- Descendant · cites it directly · 12 of its ownK040498 MyshellSedat S.A. · 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)
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 34 · See all- K042060Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004 · cites it directly17descendants
- K040498MyshellSedat S.A. · 2004 · cites it directly12descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| 0 (this device) | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | — |
| +1 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| +1 | K040498 | Myshell | Sedat S.A. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 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), 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 |
|---|---|---|---|
| * | K854261 | Advanced Cardiovascular Systems Hemostatic ValvesSummary page 1…the Guidant COPILOT™ Bleedback Control Valve are substantially equivalent with regard to these features in the predicate device, the ACS .096” Rotating Hemostatic Valve (K854261). The COPILOT™ Bleedback Control Valve has a 0.096” (2.44 mm) inside diameter. This device has two seals that operate independen… | 1985 |
What descends from it? (34)
See all 347 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042060 | Easypass US Y-Connector Hemostatic Valve | 2004 | 17 |
| K040498 | Myshell | 2004 | 12 |
| K052381 | Guardian Hemostasis Valve with Guidewire Introducer | 2005 | 11 |
| K073260 | Liisa Lever Integrated Interventional System Adapter, Model VSL-109 | 2008 | 0 |
| K072745 | Y-Glide | 2008 | 0 |
| K031903 | Rapido Cut-Away Bleedback Control Valve (BBCV), Model 7568 | 2004 | 0 |
| K021282 | LV-1 Hemostasis Valve, Model #6789 | 2002 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2011 | Not classified | Z-2792-2011 | Process control | Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO… |
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?
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 COPILOT™ Bleedback Control Valve is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter < 0.096” during interventional procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991102: Copilot Bleedback Control Valve, Model 1003331.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991102
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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