510(k) · Cleared
ClearedGunther Tulip Vena Cava Filter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DTK Filter, Intravascular, Cardiovascular
Cleared on May 5, 2005 as substantially equivalent to K000855 (Cook, Inc., 2000) and 1 other predicate after a 136-day review. Its family tree reaches back 5 generations to 1990. 1 of the 12 devices in its family, counting itself, has a Class I recall.
- Decided
- May 5, 2005
- Review
- 136 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K901502 (1990). 11 ancestors in all. No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 4 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 3 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- 2 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- 1 generation backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- This deviceK043509 Gunther Tulip Vena Cava Filter SetCook, Inc. · 2005
Class I recalls in this family
- K970466 Radius Ptca Guidewire3 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −4 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −3 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| −2 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| −1 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| 0 (this device) | K043509 | Gunther Tulip Vena Cava Filter Set | Cook, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 1 |
| 1998 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K000855 | Gunther Tulip Vena Cava Mreye Filter SetSummary page 1…Filter Set is similar in terms of intended use, materials of construction and technological characteristics as the predicate Gunther Tulip MReye TM Vena Cava Filter Set (K000855) and the GUnther TulipTM Vena Cava Filter and Retrieval Set (K032426). Device Description: The Gunther Tulip Vena Cava Filter… | 2000 |
| * | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetSummary page 1…tion and technological characteristics as the predicate Gunther Tulip MReye TM Vena Cava Filter Set (K000855) and the GUnther TulipTM Vena Cava Filter and Retrieval Set (K032426). Device Description: The Gunther Tulip Vena Cava Filter is crafted of an alloy consisting of Co, Cr, NI, Mo and Fe. The basic… | 2003 |
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 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K000855.
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 GOnther TulipTM Vena Cava Filter Set is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: * Pulmonary thromboembolism when antic-agulation therapy is contraindicated; * failure of anticoagulation therapy in thromboembolic diseases; * emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and * chronic, recurrent…
Read the full statement (133 words)
The GOnther TulipTM Vena Cava Filter Set is indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
* Pulmonary thromboembolism when antic-agulation therapy is contraindicated;
* failure of anticoagulation therapy in thromboembolic diseases;
* emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
* chronic, recurrent pulmonary embolism where anticoagulation therapy has failed or is contraindicated.
The Gunther TulipTM Vena Cava FilterTM may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure
The Gunther Tulip TM Vena Cava Filter Retrieval Set has been designed for retrieval of an implanted Gunther TulipTM Vena Cava Filter 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/K043509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043509: Gunther Tulip Vena Cava Filter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043509
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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