510(k) · Cleared
ClearedGünther Tulip Vena Cava Filter Set for Femoral 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 Nov 20, 2017 as substantially equivalent to K121057 (William Cook Europe Aps, 2012) after an 84-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Nov 20, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090140 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK090140 Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2009
- 1 generation backK121057 Cook Celect and Gunther Tulip Vena Cava Filter SetsWilliam Cook Europe Aps · 2012
- This deviceK172584 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2017
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 | K121057 | Cook Celect and Gunther Tulip Vena Cava Filter Sets | William Cook Europe Aps | 2012 | — |
| 0 (this device) | K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip… | William Cook Europe Aps | 2017 | — |
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 |
|---|---|---|---|
| * | K121057 | Cook Celect and Gunther Tulip Vena Cava Filter SetsSummary 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 K121057 on 04 May 2012. Comparison to Predicate Device: It has been demonstrated that the subject Günther Tulip Vena Cava Filter Sets a… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K121057.
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/K172584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172584: Günther Tulip Vena Cava Filter Set for Femoral 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 6, 2026. https://510kreport.com/device/K172584
Report an extraction error
Are you the manufacturer?
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