510(k) · Cleared
ClearedColign
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jilin Coronado Medical, Ltd. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Cleared on Aug 28, 2013 as substantially equivalent to K042060 (Millimed A/S, 2004) after a 128-day review. Its family tree reaches back 3 generations to 1985. 1 later device descends from it.
- Decided
- Aug 28, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- DTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K854261 (1985). 1 later device descends from it, 1 citing it directly.
- 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 deviceK131124 ColignJilin Coronado Medical, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK153685 Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. · 2016 · cites it directly0descendants
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) | K131124 | Colign | Jilin Coronado Medical, Ltd. | 2013 | — |
| +1 | K153685 | Sunmed Haemostatic Valves | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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.
Planning a device in DTL? 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 |
|---|---|---|---|
| * | K042060 | Easypass US Y-Connector Hemostatic ValveSummary page 1…te devices is used to determine the substantial equivalence between the CoLign Hemostasis Valve and the EasyPassT Y-connector Hemostatic Valve marketed by Millimed A/S(# K042060) 4 Device Description The CoLign Hemostasis Valve is a device that can be operated with only one hand through its special "push… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153685 | Sunmed Haemostatic Valves | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K153685 (Sunny Medical Device (Shenzhen) Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K042060.
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. 2013, 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 CoLign™ Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French or smaller.
The insertion tool facilitates introduction of the guide wire go through the hemostasis valve.
The torquer when inserted into 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/K131124 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131124: Colign.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131124
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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