510(k) · Cleared
ClearedGunhter Tulip Vena Cava Mreye Filter and Retrieval 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 Oct 31, 2003 as substantially equivalent to K000855 (Cook, Inc., 2000) and 2 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1990. 4 of the 42 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it.
- Decided
- Oct 31, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K901502 (1990). 10 ancestors in all. 31 later devices descend from it, 4 citing it directly. 4 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 3 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 2 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- 1 generation backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- This deviceK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- Descendant · cites it directly · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
- Descendant · 2 generations on · 6 of its ownK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
- Descendant · cites it directly · 6 of its ownK081410 Option Vena Cava FilterRex Medical · 2009
- Descendant · cites it directly · 5 of its ownK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · cites it directly16descendants
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 2 generations on6descendants
- K081410Option Vena Cava FilterRex Medical · 2009 · cites it directly6descendants
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation · 2004 · cites it directly5descendants
- K162875Sentry IVC filterNovate Medical, Ltd. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −3 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −2 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| −1 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| 0 (this device) | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| +1 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
| +2 | K112185 | Foursnare Vascular Retrieval Snare | Cook, Inc. | 2011 | Class I |
| +1 | K081410 | Option Vena Cava Filter | Rex Medical | 2009 | — |
| +1 | K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable… | Cordis Corporation | 2004 | Class I |
| +2 | K162875 | Sentry IVC filter | Novate Medical, Ltd. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2011 | 1 | 1 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (3)
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 Set | 2000 |
| * | K972511 | Amplatz Goose Neck Snare Kit/ CatheterSummary page 1…The subject devices are substantially equivalent to predicate devices: Gunther TulipTM Vena Cava MReye' Filter, #KO00855 (Cook Incorporated); Amplatz Goose Neck Snare, #K9725 11 (Microvena Corp.); and the Radius Microsnare, #KO22201 (Radius Medical Technologies).… | 1998 |
| * | K022201 | Radius Micro Snare | 2003 |
What descends from it? (31)
See all 314 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | 2008 | 16 |
| K081410 | Option Vena Cava Filter | 2009 | 6 |
| K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter… Class I | 2004 | 5 |
| K043509 | Gunther Tulip Vena Cava Filter Set | 2005 | 0 |
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.
- K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K073374 (William Cook Europe Aps, 2008) has gone furthest, with 16 descendants of its own.
- 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 Gunther Tulip 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 anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent pulmonary…
Read the full statement (128 words)
The Gunther Tulip 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 anticoagulant therapy is contraindicated;
Failure of anticoagulant therapy in thromboembolic diseases;
Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and
Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
The Gunther Tulip Vena Cava Filter may be retrieved according to the instructions supplied in the section labeled: Optional Retrieval Procedure.
The Gunther Tulip Vena Cava Filter Retrieval Set has been designed for retrieval of an implanted Gunther Tulip 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/K032426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032426: Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032426
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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