510(k) · Cleared
Recalled · Class II · 2025Option Elite Vena Cava Filter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rex Medical, L.P. · DTK Filter, Intravascular, Cardiovascular
Cleared on Dec 17, 2013 as substantially equivalent to K081410 (Rex Medical, 2009) after a 56-day review. Its family tree reaches back 6 generations to 1990. 1 of the 27 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 17, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K901502 (1990). 24 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 27 devices in this family, counting this one, has 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 backK081410 Option Vena Cava FilterRex Medical · 2009
- This deviceK133243 Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013
- Descendant · cites it directly · 1 of its ownK143405 Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P. · 2015
- Descendant · cites it directly · 0 of its ownK242612 Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. · 2024
Class I recalls in this family
- K970466 Radius Ptca Guidewire4 generations back · 1997
Most influential descendants
Showing 2 of 2 · See allView 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 | K081410 | Option Vena Cava Filter | Rex Medical | 2009 | — |
| 0 (this device) | K133243 | Option Elite Vena Cava Filter System | Rex Medical, L.P. | 2013 | — |
| +1 | K143405 | Option (TM) ELITE Vena Cava Filter 100cm System | Rex Medical, L.P. | 2015 | — |
| +1 | K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | Argon Medical Devices, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 1 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K081410 | Option Vena Cava FilterSummary page 1…Cava Filter System Common Name: Cardiovasculiar Intravascular Filter (21 CFR 870.3375, Product Code DTK) Predicate Device(s): K08141 0 Optiont m Vena Cava Filter System Device Description The OptionTMt ELITE Vena Cava Filter is designed for the preven… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2025 | Class II | Z-0589-2026 | Equipment maintenance | Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied |
| Jun 8, 2023 | Class II | Z-2239-2023 | Under Investigation by firm | There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism. |
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.
- 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 23 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 5 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143405 (Rex Medical, L.P., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K081410.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Option ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions: * Pulmonary thromboembolism when anticoagulant therapy is contraindicated; * Failure of anticoagulant therapy in thromboembolic diseases; * Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced; * Chronic, recurrent…
Read the full statement (108 words)
The Option ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:
* Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
* Failure of anticoagulant therapy in thromboembolic diseases;
* Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced;
* Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated
The filter may be retrieved according to the instructions supplied in section entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133243 · printed Nov 3, 2026
Cite this page
510(k) Report. “K133243: Option Elite Vena Cava Filter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K133243
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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