510(k) · Cleared
Recalled · Class III · 2019Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther 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 Nov 20, 2017 as substantially equivalent to K090140 (William Cook Europe Aps, 2009) after an 88-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 20, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090140 (2009). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK090140 Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2009
- This deviceK172557 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2017
- Descendant · cites it directly · 1 of its ownK211874 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK233680 Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090140 | Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter | William Cook Europe Aps | 2009 | — |
| 0 (this device) | K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip… | William Cook Europe Aps | 2017 | — |
| +1 | K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip… | William Cook Europe Aps | 2021 | 1 |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K090140 | Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterSummary page 5…Predicate Device: The Günther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate devices: • Günther Tulip Vena Cava Filter Sets cleared under K090140 on 03 April 2009. Comparison to Predicate Device: It has been demonstrated that the subject Günther Tulip Vena Cava Filter Sets… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava… | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2019 | Class III | Z-1021-2019 | Labeling Change Control | Updates to the Instructions for Use. |
| Feb 25, 2019 | Class III | Z-1022-2019 | Labeling Change Control | Updates to the Instructions for Use. |
| Feb 25, 2019 | Class III | Z-1023-2019 | Labeling Change Control | Updates to the Instructions for Use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Günther 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 Günther 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 Günther 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 as stated in the FDA summary.
https://510kreport.com/device/K172557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172557: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther 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 6, 2026. https://510kreport.com/device/K172557
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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