510(k) · Cleared
Recalled · Class I · 2013Optease Vena Cava Filter and Retrieval Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp., A Johnson & Johnson Co. · DTK Filter, Intravascular, Cardiovascular
Cleared on Feb 4, 2010 as substantially equivalent to K034050 (Cordis Corporation, 2004) and 1 other predicate after a 296-day review. Its family tree reaches back 6 generations to 1990. 4 of the 32 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Feb 4, 2010
- Review
- 296 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 6 generations to K901502 (1990). 30 ancestors in all. 1 later device descends from it, 1 citing it directly. 4 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 5 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 4 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- 3 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- 2 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- 1 generation backK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)
- This deviceK091077 Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010
- Descendant · cites it directly · 0 of its ownK140286 Optease Vena Cava Filter and Optease Retrieval CathteterCordis, A Johnson & Johnson Co. · 2014
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K140286Optease Vena Cava Filter and Optease Retrieval CathteterCordis, A Johnson & Johnson Co. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −5 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −4 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| −3 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| −2 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| −1 | K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable… | Cordis Corporation | 2004 | Class I |
| 0 (this device) | K091077 | Optease Vena Cava Filter and Retrieval Catheter | Cordis Corp., A Johnson & Johnson Co. | 2010 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
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…The device is substantially equivalent to: Predicate * Cordis OPTEASE® Vena Cava Filter and OPTEASE® Retrieval Devices Catheter (ref. 5 10(k) K034050) * G2 EXPRESS Filter System, Bard Peripheral Vascular, Inc. (ref. 5 10(k) K082305) Perf… | 2004 |
| * | K082305 | G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsSummary page 1…al Devices Catheter (ref. 5 10(k) K034050) * G2 EXPRESS Filter System, Bard Peripheral Vascular, Inc. (ref. 5 10(k) K082305) Performance As per 21 CFR 870.3375, the following special controls were established for Standards cardiovascular intra… | 2008 |
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 |
|---|---|---|---|
| K140286 | Optease Vena Cava Filter and Optease Retrieval Cathteter | 2014 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2013 | Class II | Z-0081-2014 | Error in labeling | Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down… |
| Mar 29, 2013 | Class I | Z-1887-2013 | Labeling design | Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards. |
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 · 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 20 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 7 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K140286 (Cordis, A Johnson & Johnson Co., 2014) has gone furthest, with 0 descendants of its own.
- 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. 2010, 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 contrairndicated, * Failure of anticoagulant therapy for thromboembolic disease, * Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced. * Chronic, recurrent pulmonary…
Read the full statement (118 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 contrairndicated,
* 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 radiopaque contrast media
to the vena cava.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091077: Optease Vena Cava Filter and Retrieval Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091077
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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