510(k) · Cleared
ClearedGunther Tulip Vena Cava Mreye 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 Oct 18, 2000 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.
- Decided
- Oct 18, 2000
- Review
- 216 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 3 citing it directly. 3 of the 34 devices in this family, counting this one, have a Class I recall.
- This deviceK000855 Gunther Tulip Vena Cava Mreye Filter SetCook, Inc. · 2000
- Descendant · cites it directly · 31 of its ownK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- Descendant · cites it directly · 17 of its ownK061815 Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2007
- Descendant · 2 generations on · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
- Descendant · 3 generations on · 6 of its ownK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK081410 Option Vena Cava FilterRex Medical · 2009
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · See all- K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003 · cites it directly31descendants
- K061815Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2007 · cites it directly17descendants
- K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · 2 generations on16descendants
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 3 generations on6descendants
- K081410Option Vena Cava FilterRex Medical · 2009 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000855 | Gunther Tulip Vena Cava Mreye Filter Set | Cook, Inc. | 2000 | — |
| +1 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| +1 | K061815 | Cook Celect Vena Cava Filter | William Cook Europe Aps | 2007 | — |
| +2 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
| +3 | K112185 | Foursnare Vascular Retrieval Snare | Cook, Inc. | 2011 | Class I |
| +2 | K081410 | Option Vena Cava Filter | Rex Medical | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
| 2005 | 1 | 0 |
| 2007 | 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (33)
See all 333 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K032426 (Cook, Inc., 2003) has gone furthest, with 31 descendants of its own.
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 | — |
https://510kreport.com/device/K000855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000855: Gunther Tulip Vena Cava Mreye 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/K000855
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026