510(k) · Cleared
ClearedModification to G2 Filter System-Femoral Delivery Kit, Model RF-310F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular · DTK Filter, Intravascular, Cardiovascular
Cleared on Oct 26, 2006 as substantially equivalent to K050558 (C.R. Bard, Inc., 2005) after a 30-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.
- Decided
- Oct 26, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- 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 deviceK062887 Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FBard Peripheral Vascular · 2006
- 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) | K062887 | Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310F | Bard Peripheral Vascular | 2006 | — |
| +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 1…fication: Class 11 Classification Panel: Cardiovascular 3. Predicate Device: G2TM Filter System - Femoral Delivery Kit (K050558, cleared 8/29/05) 4. Summary of Change: The design modification to the G2'M Filter System - Femoral Delivery… | 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)
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 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 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 - Femoral 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/K062887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062887: Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062887
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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