510(k) · Decided
Recalled · 2006Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular, Inc. · DTK Filter, Intravascular, Cardiovascular
Cleared on Nov 25, 2005 as substantially equivalent to K050558 (C.R. Bard, Inc., 2005) after a 66-day review. Its family tree reaches back 2 generations to 2002. 1 of the 25 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 25, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- DTK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022236 (2002). 3 ancestors in all. 21 later devices descend from it, 1 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
- 1 generation backK050558 Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005
- This deviceK052578 Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005
- Descendant · cites it directly · 20 of its ownK073090 Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc. · 2008
- Descendant · 2 generations on · 12 of its ownK080668 G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian…C.R. Bard, Inc. · 2008
- Descendant · 3 generations on · 11 of its ownK082305 G2 Express Filter System - Femoral and Jugular/Subclavian Delivery…C.R. Bard, Inc. · 2008
- Descendant · 4 generations on · 8 of its ownK093659 Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter…C.R. Bard, Inc. · 2010
- Descendant · 5 generations on · 6 of its ownK101431 Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K091077 Optease Vena Cava Filter and Retrieval Catheter4 generations on · 2010
Most influential descendants
Showing 5 of 21 · See all- K073090Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain…C.R. Bard, Inc. · 2008 · cites it directly20descendants
- K080668G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery KitsC.R. Bard, Inc. · 2008 · 2 generations on12descendants
- K082305G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2008 · 3 generations on11descendants
- K093659Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian…C.R. Bard, Inc. · 2010 · 4 generations on8descendants
- K101431Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022236 | Recovery Filter System, Model RF-048F | C.R. Bard, Inc. | 2002 | — |
| −1 | K050558 | Modification to: Recovery Filter System, Model RF-210F | C.R. Bard, Inc. | 2005 | — |
| 0 (this device) | K052578 | Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J | Bard Peripheral Vascular, Inc. | 2005 | — |
| +1 | K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F… | C.R. Bard, Inc. | 2008 | — |
| +2 | K080668 | G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J)… | C.R. Bard, Inc. | 2008 | — |
| +3 | K082305 | G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits | C.R. Bard, Inc. | 2008 | — |
| +4 | K093659 | Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter… | C.R. Bard, Inc. | 2010 | — |
| +5 | K101431 | Eclipse Filter System-Femoral and Jugular/Subclavian Delivery Kits | C.R. Bard, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 1 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K050558 | Modification to: Recovery Filter System, Model RF-210FSummary page 2…ssification: Class II Classification Panel: Cardiovascular 3. Predicate Device: G2Tm Filter System - Femoral Delivery Kit (K050558, cleared 8/29/05) Bard Peripheral Vascular, Inc TRADE SECRET/CONFIDENTIAL INFORMATION… | 2005 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain… | 2008 | 20 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2006 | Not classified | Z-0393-2007 | Other | This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity. |
| Dec 20, 2006 | Not classified | Z-0394-2007 | Other | This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity. |
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 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073090 (C.R. Bard, Inc., 2008) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K050558.
How does its category compare?
All DTK devicesDTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TM Filter System - Jugular/Subclavian Delivery Kit is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052578: Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052578
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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