510(k) · Cleared
ClearedOptease Vena Cava Filter and Optease Retrieval Cathteter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis, A Johnson & Johnson Co. · DTK Filter, Intravascular, Cardiovascular
Cleared on Mar 7, 2014 as substantially equivalent to K034050 (Cordis Corporation, 2004) and 1 other predicate after a 30-day review. Its family tree reaches back 7 generations to 1990. 4 of the 32 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 7, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K901502 (1990). 31 ancestors in all. No later device cites it as a predicate yet. 4 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 6 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 5 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- 4 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- 3 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- 2 generations backK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)
- 1 generation backK091077 Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · Recalled (Class I)
- This deviceK140286 Optease Vena Cava Filter and Optease Retrieval CathteterCordis, A Johnson & Johnson Co. · 2014
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −6 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −5 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| −4 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| −3 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| −2 | K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable… | Cordis Corporation | 2004 | Class I |
| −1 | K091077 | Optease Vena Cava Filter and Retrieval Catheter | Cordis Corp., A Johnson & Johnson Co. | 2010 | Class I |
| 0 (this device) | K140286 | Optease Vena Cava Filter and Optease Retrieval Cathteter | Cordis, A Johnson & Johnson Co. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1997 | 2 | 1 |
| 1998 | 3 | 0 |
| 1999 | 1 | 1 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 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.
4 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? (2)
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 |
|---|---|---|---|
| * | K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Summary page 1…DTK PREDICATE DEVICE OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Catheter Previously cleared under K034050 and again under K09 1077… | 2004 |
| * | K091077 | Optease Vena Cava Filter and Retrieval CatheterSummary page 1…ava Filter and OPTEASE® Retrieval Catheter Previously cleared under K034050 and again under K09 1077 K 140286… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K992347Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker BandsCordis Corp. · 1999 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 15 Class I recalls
- K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 8 of the 31 ancestors have a recall of any class; 4 have a Class I recall.
- 2 other devices also cite its predicate K034050.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: *Pulmonary thromboembolism when anticoagulants are contraindicated, *Failure of anticoagulant therapy for thromboembolic disease, *Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced, *Chronic, recurrent pulmonary embolism…
Read the full statement (115 words)
The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism
(PE) via percutaneous placement in the vena cava in the following situations:
*Pulmonary thromboembolism when anticoagulants are contraindicated,
*Failure of anticoagulant therapy for thromboembolic disease,
*Emergency treatment following massive pulmonary embolism where anticipated benefits of
conventional therapy are reduced,
*Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is
contraindicated
The OPTEASE Filter may be retrieved according to the instructions supplied in the Section
labeled: "Optional Procedure for Filter Retrieval".
The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear
measurement of the vasculature when combined with the delivery of the radiopaque contrast
media to the vena cava.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140286: Optease Vena Cava Filter and Optease Retrieval Cathteter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140286
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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