510(k) · Cleared
ClearedCook 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 20, 2007 as substantially equivalent to K000855 (Cook, Inc., 2000) after a 297-day review. Its family tree reaches back 1 generation to 2000. 1 of the 19 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Apr 20, 2007
- Review
- 297 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000855 (2000). 17 later devices descend from it, 1 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK000855 Gunther Tulip Vena Cava Mreye Filter SetCook, Inc. · 2000
- This deviceK061815 Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2007
- Descendant · cites it directly · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
- Descendant · 2 generations on · 6 of its ownK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK152560 Bard Snare Retrieval KitNeometrics, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK222083 LimFlow V-CeiverLimFlow, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK191758 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K112185 Foursnare Vascular Retrieval Snare2 generations on · 2011
Most influential descendants
Showing 5 of 17 · See all- K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · cites it directly16descendants
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 2 generations on6descendants
- K152560Bard Snare Retrieval KitNeometrics, Inc. · 2015 · 2 generations on2descendants
- K222083LimFlow V-CeiverLimFlow, Inc. · 2022 · 3 generations on1descendant
- K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000855 | Gunther Tulip Vena Cava Mreye Filter Set | Cook, Inc. | 2000 | — |
| 0 (this device) | K061815 | Cook Celect Vena Cava Filter | William Cook Europe Aps | 2007 | — |
| +1 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
| +2 | K112185 | Foursnare Vascular Retrieval Snare | Cook, Inc. | 2011 | Class I |
| +2 | K152560 | Bard Snare Retrieval Kit | Neometrics, Inc. | 2015 | — |
| +3 | K222083 | LimFlow V-Ceiver | LimFlow, Inc. | 2022 | — |
| +3 | K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K000855 | Gunther Tulip Vena Cava Mreye Filter SetSummary page 1…21 CFR 870.3375, Product Code DTK Substantial Equivalence: The Cook Celect Vena. Cava Filter is substantially equivalent to the Gilnther Tulip Vena Cava Filter (#K000855, cleared on 18 October 2000), which is currently marketed. The Cook Celect Vena. Cava Filter, the subject of this submission, is… | 2000 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | 2008 | 16 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 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. 2007, 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 Cook Celect Vena Cava Filter 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 pulmonary embolism when anticipated benefits of conventional therapy are reduced; and * Chronic, recurrent pulmonary…
Read the full statement (113 words)
The Cook Celect Vena Cava Filter 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 pulmonary embolism when anticipated benefits of conventional therapy are reduced; and
* Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated.
The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary thromboembolism. The filter is compatible with placement in vena cava diameters between 15 and 30 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061815: 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/K061815
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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