510(k) · Cleared
ClearedRecovery Filter System, Model RF-048F
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 25, 2003 after an 88-day review. The FDA summary names its predicate without a number. 2 of the 31 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it.
- Decided
- Jul 25, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 4 citing it directly. 2 of the 31 devices in this family, counting this one, have a Class I recall.
- This deviceK031328 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2003
- Descendant · cites it directly · 23 of its ownK050558 Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005
- Descendant · 2 generations on · 21 of its ownK062887 Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FBard Peripheral Vascular · 2006
- Descendant · 2 generations on · 21 of its ownK052578 Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 20 of its ownK073090 Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc. · 2008
- Descendant · 4 generations on · 12 of its ownK080668 G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian…C.R. Bard, Inc. · 2008
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K050558Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005 · cites it directly23descendants
- K062887Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FBard Peripheral Vascular · 2006 · 2 generations on21descendants
- K052578Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · 2 generations on21descendants
- K073090Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain…C.R. Bard, Inc. · 2008 · 3 generations on20descendants
- K080668G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery KitsC.R. Bard, Inc. · 2008 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031328 | Recovery Filter System, Model RF-048F | C.R. Bard, Inc. | 2003 | — |
| +1 | K050558 | Modification to: Recovery Filter System, Model RF-210F | C.R. Bard, Inc. | 2005 | — |
| +2 | K062887 | Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310F | Bard Peripheral Vascular | 2006 | — |
| +2 | K052578 | Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J | Bard Peripheral Vascular, Inc. | 2005 | 2 |
| +3 | K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F… | C.R. Bard, Inc. | 2008 | — |
| +4 | K080668 | G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J)… | C.R. Bard, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 1 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | — | Recovery Filter System Named without a submission number |
What descends from it? (30)
See all 304 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050558 | Modification to: Recovery Filter System, Model RF-210F | 2005 | 23 |
| K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter… Class I | 2004 | 5 |
| K070514 | Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach… | 2008 | 1 |
| K113124 | Aln Optional Vana Cava Filter | 2012 | 0 |
Has anything in its family been recalled? (2 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.
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- 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?
- Of its descendants, K050558 (C.R. Bard, Inc., 2005) has gone furthest, with 23 descendants of its own.
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 Recovery Filter System 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
Recovery filter may be removed according to the instructions supplied in the Section
labeled: Optional Procedure for Filter Removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031328 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031328: Recovery Filter System, Model RF-048F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031328
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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