510(k) · Cleared
Recalled · Class III · 2022Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
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 Jul 28, 2021 as substantially equivalent to K172557 (William Cook Europe Aps, 2017) after a 41-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 28, 2021
- Review
- 41 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090140 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK090140 Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2009
- 1 generation backK172557 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2017 · Recalled
- This deviceK211874 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2021
- Descendant · cites it directly · 0 of its ownK233680 Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2024
Most influential descendants
Showing 1 of 1 · See all- K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 |
| 0 (this device) | K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip… | William Cook Europe Aps | 2021 | — |
| +1 | K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach… | William Cook Europe Aps | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava…Summary page 5…5 === Predicate Devices: The subject Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices, the Günther Tulip Vena Cava Filter Sets (K172557, cleared 20 November 2017). Comparison to Predicate Device: It has been demonstrated that the subject Günther Tulip Vena Cava F… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2022 | Class III | Z-0875-2022 | Labeling design | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 8.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K233680 (William Cook Europe Aps, 2024) has gone furthest, with 0 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. 2021, 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 Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) 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 PE where anticipated benefits of conventional therapy are reduced; and * Chronic, recurrent PE where anticoagulant…
Read the full statement (119 words)
The Giinther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) 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 PE where anticipated benefits of conventional therapy are reduced; and
* Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.
The Giinther Tulip Filter implant may be retrieved if clinically indicated; please refer to the “Optional Filter Retrieval” section of the Instructions for Use for more information.
The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211874: Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211874
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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