510(k) · Cleared
ClearedGunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
William Cook Europe Aps · DTK Filter, Intravascular, Cardiovascular
Cleared on Apr 3, 2009 after a 72-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Apr 3, 2009
- Review
- 72 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK090140 Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2009
- Descendant · cites it directly · 2 of its ownK172557 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK121057 Cook Celect and Gunther Tulip Vena Cava Filter SetsWilliam Cook Europe Aps · 2012
- Descendant · 2 generations on · 1 of its ownK211874 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK233680 Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2024
- Descendant · 2 generations on · 0 of its ownK172584 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K172557Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava…William Cook Europe Aps · 2017 · cites it directly2descendants
- K121057Cook Celect and Gunther Tulip Vena Cava Filter SetsWilliam Cook Europe Aps · 2012 · cites it directly2descendants
- K211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…William Cook Europe Aps · 2021 · 2 generations on1descendant
- K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2024 · 3 generations on0descendants
- K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…William Cook Europe Aps · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090140 | Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter | William Cook Europe Aps | 2009 | — |
| +1 | K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip… | William Cook Europe Aps | 2017 | 3 |
| +1 | K121057 | Cook Celect and Gunther Tulip Vena Cava Filter Sets | William Cook Europe Aps | 2012 | — |
| +2 | K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip… | William Cook Europe Aps | 2021 | 1 |
| +3 | K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach… | William Cook Europe Aps | 2024 | — |
| +2 | K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip… | William Cook Europe Aps | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2017 | 2 | 0 |
| 2021 | 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.
Planning a device in DTK? 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 |
|---|---|---|---|
| * | — | Gunther Tulip® Vena Cava Filter Named without a submission number | |
| * | — | Cook® Celect® Vena Cava Filter Named without a submission number |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava… | 2017 | 2 |
| K121057 | Cook Celect and Gunther Tulip Vena Cava Filter Sets | 2012 | 2 |
| K113124 | Aln Optional Vana Cava Filter | 2012 | 0 |
| K121629 | Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena… | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K172557 (William Cook Europe Aps, 2017) has gone furthest, with 2 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. 2009, 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 Giinther Tulip® Vena Cava Filter is intended 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 when anticipated benefits of conventional therapy are reduced; and * Chronic, recurrent pulmonary…
Read the full statement (140 words)
The Giinther Tulip® Vena Cava Filter is intended 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 when anticipated benefits of conventional therapy are reduced; and
* Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated.
The Cook® Celect® Vena Cava Filter is intended 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 when anticipated benefits of conventional therapy are reduced; and
· Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090140: Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090140
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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