510(k) · Cleared
ClearedOption ELITE Vena Cava Filter System (352506070E 352506100E)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Devices, Inc. · DTK Filter, Intravascular, Cardiovascular
Cleared on Sep 10, 2024 as substantially equivalent to K133243 (Rex Medical, L.P., 2013) and 1 other predicate after a 7-day review. Its family tree reaches back 8 generations to 1990. 1 of the 27 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 10, 2024
- Review
- 7 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K901502 (1990). 26 ancestors in all. No later device cites it as a predicate yet. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 7 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 6 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- 5 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- 4 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- 3 generations backK081410 Option Vena Cava FilterRex Medical · 2009
- 2 generations backK133243 Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · Recalled
- 1 generation backK143405 Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P. · 2015
- This deviceK242612 Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. · 2024
Class I recalls in this family
- K970466 Radius Ptca Guidewire5 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −7 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −6 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| −5 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| −4 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| −3 | K081410 | Option Vena Cava Filter | Rex Medical | 2009 | — |
| −2 | K133243 | Option Elite Vena Cava Filter System | Rex Medical, L.P. | 2013 | 2 |
| −1 | K143405 | Option (TM) ELITE Vena Cava Filter 100cm System | Rex Medical, L.P. | 2015 | — |
| 0 (this device) | 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 |
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 K240257 Denali™ Vena Cava Filter System – Femoral and…score 9.9 · 11 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 |
|---|---|---|---|
| * | K133243 | Option Elite Vena Cava Filter SystemSummary page 5…uct Code: 21 CFR Part 870.3375 / DTK Classification / Panel: Class II / Cardiovascular Predicate Devices: The Option™ELITE Vena Cava Filter System (K133243, cleared Dec. 17, 2013) and the Option™ELITE Vena Cava Filter 100cm System (K143405, cleared April 16, 2015). Summary of Change:… | 2013 |
| * | K143405 | Option (TM) ELITE Vena Cava Filter 100cm SystemSummary page 5…ss II / Cardiovascular Predicate Devices: The Option™ELITE Vena Cava Filter System (K133243, cleared Dec. 17, 2013) and the Option™ELITE Vena Cava Filter 100cm System (K143405, cleared April 16, 2015). Summary of Change: No changes have been made to the subject Option Elite Vena Cava Filter System or 10… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 4.5 years on median.
- 6 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K133243.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic disease • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent…
Read the full statement (221 words)
The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:
• Pulmonary thromboembolism when anticoagulants are contraindicated
• Failure of anticoagulant therapy in 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 Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled “Optional Procedure for Filter Retrieval” in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.
The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:
• Pulmonary thromboembolism when anticoagulants are contraindicated
• Failure of anticoagulant therapy in 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 Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled “Optional Procedure for Filter Retrieval” in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242612: Option ELITE Vena Cava Filter System (352506070E 352506100E).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242612
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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