510(k) · Cleared
ClearedG2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) 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 Jul 30, 2008 as substantially equivalent to K073090 (C.R. Bard, Inc., 2008) after a 142-day review. Its family tree reaches back 4 generations to 2002. 1 of the 19 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Jul 30, 2008
- Review
- 142 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022236 (2002). 6 ancestors in all. 12 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 · 4 generations backK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
- 3 generations backK050558 Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005
- 2 generations backK052578 Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · Recalled
- 1 generation backK073090 Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc. · 2008
- This deviceK080668 G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian…C.R. Bard, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK082305 G2 Express Filter System - Femoral and Jugular/Subclavian Delivery…C.R. Bard, Inc. · 2008
- Descendant · 2 generations on · 8 of its ownK093659 Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter…C.R. Bard, Inc. · 2010
- Descendant · 3 generations on · 6 of its ownK101431 Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010
- Descendant · 4 generations on · 3 of its ownK130366 Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery…C.R. Bard, Inc. · 2013 · Recalled
- Descendant · 5 generations on · 2 of its ownK143208 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K091077 Optease Vena Cava Filter and Retrieval Catheter2 generations on · 2010
Most influential descendants
Showing 5 of 12 · See all- K082305G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2008 · cites it directly11descendants
- K093659Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian…C.R. Bard, Inc. · 2010 · 2 generations on8descendants
- K101431Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010 · 3 generations on6descendants
- K130366Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery KitC.R. Bard, Inc. · 2013 · 4 generations on3descendants
- K143208Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain…C.R. Bard, Inc. · 2014 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022236 | Recovery Filter System, Model RF-048F | C.R. Bard, Inc. | 2002 | — |
| −3 | K050558 | Modification to: Recovery Filter System, Model RF-210F | C.R. Bard, Inc. | 2005 | — |
| −2 | K052578 | Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J | Bard Peripheral Vascular, Inc. | 2005 | 2 |
| −1 | K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F… | C.R. Bard, Inc. | 2008 | — |
| 0 (this device) | K080668 | G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J)… | C.R. Bard, Inc. | 2008 | — |
| +1 | K082305 | G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits | C.R. Bard, Inc. | 2008 | — |
| +2 | K093659 | Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter… | C.R. Bard, Inc. | 2010 | — |
| +3 | K101431 | Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits | C.R. Bard, Inc. | 2010 | — |
| +4 | K130366 | Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery Kit | C.R. Bard, Inc. | 2013 | 3 |
| +5 | K143208 | Denali Filter System - Femoral Delivery Kit, Denali Filter System -… | C.R. Bard, Inc. | 2014 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 1 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 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.
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 |
|---|---|---|---|
| * | K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain…Summary page 1…Classification: Class II Classification Panel: Cardiovascular 3. Predicate Devices: Recovery® G2® Filter System - Femoral Delivery Kit (K073090) Recovery® G2® Filter System - Jugular/Subclavian Delivery Kit (K073090) TRADE SECRET/C… | 2008 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082305 | G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits | 2008 | 11 |
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.
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K082305 (C.R. Bard, Inc., 2008) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K073090.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 G2 EXPRESS 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 (94 words)
The G2 EXPRESS 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.
G2 EXPRESS 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/K080668 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080668: G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080668
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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