510(k) · Decided
DecidedCordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · DTK Filter, Intravascular, Cardiovascular
Cleared on Oct 18, 2002 after a 29-day review. The FDA summary names its predicate without a number. 2 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Oct 18, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK023116 Cordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200BCordis Corp. · 2002
- Descendant · cites it directly · 6 of its ownK081410 Option Vena Cava FilterRex Medical · 2009
- 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 · 2 generations on · 2 of its ownK133243 Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK120402 Crux Vena Cava Filter SystemCrux Biomedical · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K081410Option Vena Cava FilterRex Medical · 2009 · cites it directly6descendants
- 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
- K133243Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · 2 generations on2descendants
- K120402Crux Vena Cava Filter SystemCrux Biomedical · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023116 | Cordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200B | Cordis Corp. | 2002 | — |
| +1 | K081410 | Option Vena Cava Filter | Rex Medical | 2009 | — |
| +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 | — |
| +2 | K133243 | Option Elite Vena Cava Filter System | Rex Medical, L.P. | 2013 | 2 |
| +2 | K120402 | Crux Vena Cava Filter System | Crux Biomedical | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2024 | 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.
2 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 DTK device
- #1 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Cordis TrapEase Permanent Vena Cava Filter and Introduction Kit Named without a submission number | |
| * | — | Cordis TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator Named without a submission number | |
| * | — | Gunther Tulip Vena Cava MReye Filter set, Cook Incorporated Named without a submission number | |
| * | — | Vena Tech LGM 30 CJ/U & 30 D/U Vena Cava Filter Named without a submission number |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- 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?
- Of its descendants, K081410 (Rex Medical, 2009) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTK
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DTK
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTK
432in 2025
MAUDE reports naming product code DTK, 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 | 3 | 87 | 1 | 364 |
| 2008 | 6 | 87 | 0 | 345 |
| 2009 | 3 | 380 | 0 | 456 |
| 2010 | 3 | 50 | 0 | 369 |
| 2011 | 2 | — | 0 | 439 |
| 2012 | 5 | 156 | 0 | 351 |
| 2013 | 3 | 91 | 1 | 473 |
| 2014 | 2 | — | 0 | 451 |
| 2015 | 2 | — | 1 | 859 |
| 2016 | 3 | 84 | 2 | 2,574 |
| 2017 | 5 | 88 | 0 | 4,364 |
| 2018 | 2 | — | 0 | 3,938 |
| 2019 | 0 | — | 6 | 6,467 |
| 2020 | 0 | — | 0 | 5,405 |
| 2021 | 2 | — | 0 | 5,357 |
| 2022 | 0 | — | 2 | 2,191 |
| 2023 | 0 | — | 0 | 583 |
| 2024 | 5 | 29 | 0 | 406 |
| 2025 | 0 | — | 1 | 432 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OptEaseTM is indicated for the prevention of recurrent pulmonary embolism via permanent, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023116: Cordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023116
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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