510(k) · Cleared
ClearedCordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator; Models 466-P306AU & 466-P306BU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · DQO Catheter, Intravascular, Diagnostic
Cleared on Mar 20, 2002 as substantially equivalent to K000062 (Cordis Corp., 2000) and 6 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1991. 3 of the 14 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Mar 20, 2002
- Review
- 49 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 1 generation to K914007 (1991). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK914007 Cordis 5.2 French Super Torque Plus Cardio CathCordis Corp. · 1991
- This deviceK020316 Cordis Trapease Permanent Vena Cava Filter with the Visease…Cordis Corp. · 2002
- Descendant · cites it directly · 5 of its ownK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK173236 Sentry IVC FilterNovate Medical, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK091077 Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK181202 Sentry IVC FilterNovate Medical, Ltd. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation · 2004 · cites it directly5descendants
- K162875Sentry IVC filterNovate Medical, Ltd. · 2017 · 2 generations on2descendants
- K173236Sentry IVC FilterNovate Medical, Ltd. · 2018 · 3 generations on1descendant
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 2 generations on1descendant
- K181202Sentry IVC FilterNovate Medical, Ltd. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914007 | Cordis 5.2 French Super Torque Plus Cardio Cath | Cordis Corp. | 1991 | — |
| 0 (this device) | K020316 | Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic… | Cordis Corp. | 2002 | — |
| +1 | K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable… | Cordis Corporation | 2004 | Class I |
| +2 | K162875 | Sentry IVC filter | Novate Medical, Ltd. | 2017 | — |
| +3 | K173236 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
| +2 | K091077 | Optease Vena Cava Filter and Retrieval Catheter | Cordis Corp., A Johnson & Johnson Co. | 2010 | Class I |
| +4 | K181202 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 1 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2010 | 1 | 1 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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.
Top candidate predicates for a new DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K000062 | Cordis Trapease Permanent Vena Cava Filter and Introduction KitSummary page 4…ena Cava Filter with the VisEase Angiographic Vessel Dilator is substantially equivalent to: e Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit (510(k) #K000062, #K003964 and #K010083) e Cordis 5F Super Torque MB Angiographic Catheter (510(k) #K992347). e Cordis 52 F Super Torque Plus An… | 2000 |
| * | K003964 | Trapease Permanent Vena Filter and Introduction Kit, Models 466-P306A and 466-P306BSummary page 4…ilter with the VisEase Angiographic Vessel Dilator is substantially equivalent to: e Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit (510(k) #K000062, #K003964 and #K010083) e Cordis 5F Super Torque MB Angiographic Catheter (510(k) #K992347). e Cordis 52 F Super Torque Plus Angiographic… | 2001 |
| * | K010083 | Trapease Permanent Vena Cava Filter and Introduction Kit, Model 466-P306ASummary page 4…e VisEase Angiographic Vessel Dilator is substantially equivalent to: e Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit (510(k) #K000062, #K003964 and #K010083) e Cordis 5F Super Torque MB Angiographic Catheter (510(k) #K992347). e Cordis 52 F Super Torque Plus Angiographic Catheter (51… | 2001 |
| * | K992347 | Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker BandsSummary page 4…: e Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit (510(k) #K000062, #K003964 and #K010083) e Cordis 5F Super Torque MB Angiographic Catheter (510(k) #K992347). e Cordis 52 F Super Torque Plus Angiographic Catheter (510(k) #K914007) e Cordis Brite Tip Catheter Sheath Introducer & Vesse… | 1999 |
| * | K914007 | Cordis 5.2 French Super Torque Plus Cardio CathSummary page 4…k) #K000062, #K003964 and #K010083) e Cordis 5F Super Torque MB Angiographic Catheter (510(k) #K992347). e Cordis 52 F Super Torque Plus Angiographic Catheter (510(k) #K914007) e Cordis Brite Tip Catheter Sheath Introducer & Vessel Dilator (510(k) #K983023 and #K984500) TRAPEASE™ Permane… | 1991 |
| * | K983023 | Modification to Cordis Brite Tip Catheter Sheath Introducer SystemSummary page 4…eter (510(k) #K992347). e Cordis 52 F Super Torque Plus Angiographic Catheter (510(k) #K914007) e Cordis Brite Tip Catheter Sheath Introducer & Vessel Dilator (510(k) #K983023 and #K984500) TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vesse! Dilator Cordis Corporati… | 1998 |
| * | K984500 | Cordis Brite Tip Catheter Sheath Introducer SystemSummary page 4…#K992347). e Cordis 52 F Super Torque Plus Angiographic Catheter (510(k) #K914007) e Cordis Brite Tip Catheter Sheath Introducer & Vessel Dilator (510(k) #K983023 and #K984500) TRAPEASE™ Permanent Vena Cava Filter with the VISEASE™ Angiographic Vesse! Dilator Cordis Corporation, a Johnson… | 1998 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter… Class I | 2004 | 5 |
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.
- K992347Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker BandsCordis Corp. · 1999 · Direct predicate · ◆ in the 1999 ancestors bar of FIG. 15 Class I recalls
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Cordis TrapEase™ Permanent Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations: pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and chronic…
Read the full statement (98 words)
The Cordis TrapEase™ Permanent Vena Cava Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in the following situations: pulmonary thromboembolism when anticoagulants are contraindicated, failure of anticoagulant therapy in thromboembolic diseases, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The VisEase Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava.
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/K020316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020316: Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator; Models 466-P306AU & 466-P306BU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020316
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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