510(k) · Cleared
Recalled · Class III · 2019Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum 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 Aug 7, 2017 after a 59-day review. The FDA summary names no predicate by number. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 7, 2017
- Review
- 59 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK171712 Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2017
- Descendant · cites it directly · 1 of its ownK211875 Cook Celect Platinum 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 |
|---|---|---|---|---|---|
| 0 (this device) | K171712 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook… | William Cook Europe Aps | 2017 | — |
| +1 | K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook… | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect… | 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-1024-2019 | Labeling Change Control | Updates to the Instructions for Use. |
| Feb 25, 2019 | Class III | Z-1025-2019 | Labeling Change Control | Updates to the Instructions for Use. |
| Feb 25, 2019 | Class III | Z-1026-2019 | Labeling Change Control | Updates to the Instructions for Use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211875 (William Cook Europe Aps, 2021) has gone furthest, with 1 descendant 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. 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 | — |
https://510kreport.com/device/K171712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171712: Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum 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/K171712
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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