510(k) · Cleared
ClearedEclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DTK Filter, Intravascular, Cardiovascular
Cleared on Jun 25, 2010 as substantially equivalent to K093659 (C.R. Bard, Inc., 2010) after a 35-day review. Its family tree reaches back 7 generations to 2002. 6 later devices descend from it.
- Decided
- Jun 25, 2010
- Review
- 35 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K022236 (2002). 9 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
- 6 generations backK050558 Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005
- 5 generations backK052578 Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · Recalled
- 4 generations backK073090 Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc. · 2008
- 3 generations backK080668 G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian…C.R. Bard, Inc. · 2008
- 2 generations backK082305 G2 Express Filter System - Femoral and Jugular/Subclavian Delivery…C.R. Bard, Inc. · 2008
- 1 generation backK093659 Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter…C.R. Bard, Inc. · 2010
- This deviceK101431 Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK130366 Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery…C.R. Bard, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK143208 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK160866 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK102511 Meridan Filter System- Jungular/Subeclavian Delivery KitC.R. Bard, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK240257 Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian…Bd · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K130366Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery KitC.R. Bard, Inc. · 2013 · cites it directly3descendants
- K143208Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain…C.R. Bard, Inc. · 2014 · 2 generations on2descendants
- K160866Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian…C.R. Bard, Inc. · 2016 · 3 generations on1descendant
- K102511Meridan Filter System- Jungular/Subeclavian Delivery KitC.R. Bard, Inc. · 2011 · cites it directly1descendant
- K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBd · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K022236 | Recovery Filter System, Model RF-048F | C.R. Bard, Inc. | 2002 | — |
| −6 | K050558 | Modification to: Recovery Filter System, Model RF-210F | C.R. Bard, Inc. | 2005 | — |
| −5 | K052578 | Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J | Bard Peripheral Vascular, Inc. | 2005 | 2 |
| −4 | K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F… | C.R. Bard, Inc. | 2008 | — |
| −3 | K080668 | G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J)… | C.R. Bard, Inc. | 2008 | — |
| −2 | K082305 | G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits | C.R. Bard, Inc. | 2008 | — |
| −1 | K093659 | Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter… | C.R. Bard, Inc. | 2010 | — |
| 0 (this device) | K101431 | Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits | C.R. Bard, Inc. | 2010 | — |
| +1 | K130366 | Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery Kit | C.R. Bard, Inc. | 2013 | 3 |
| +2 | K143208 | Denali Filter System - Femoral Delivery Kit, Denali Filter System -… | C.R. Bard, Inc. | 2014 | — |
| +3 | K160866 | Denali Filter System - Femoral Delivery Kit, Denali Filter System -… | C.R. Bard, Inc. | 2016 | — |
| +1 | K102511 | Meridan Filter System- Jungular/Subeclavian Delivery Kit | C.R. Bard, Inc. | 2011 | — |
| +4 | K240257 | Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit | Bd | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K093659 | Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian…Summary page 1…: DTK Predicate Devices: ECLIPSE Tm Filter System - Femoral and Jugular/Subclavian Delivery Kits (K093659) Summary of Change: The> primary modification from the predicate device, the ECLIPSE Tm Filter System - Femoral and Jugular/Subcl… | 2010 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 companies; a new generation was cleared every 6 months on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K130366 (C.R. Bard, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K093659.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ECLIPSE Tm Filter System - Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations: *Pulmonary thromboembolism when anticoagulants are contraindicated. *Failure of anticoagulant therapy for thromboembolic disease. *Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy…
Read the full statement (92 words)
The ECLIPSE Tm Filter System - Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
*Pulmonary thromboembolism when anticoagulants are contraindicated.
*Failure of anticoagulant therapy for thromboembolic disease.
*Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
*Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
ECLIPSE Tm Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101431: Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101431
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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