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 Nov 27, 2002 after a 139-day review. The FDA summary names its predicate without a number. 1 of the 25 devices in its family, counting itself, has a Class I recall. 24 later devices descend from it.
- Decided
- Nov 27, 2002
- Review
- 139 days
- Class
- Class II
- Product code
- DTK
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- This deviceK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
- 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 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K091077 Optease Vena Cava Filter and Retrieval Catheter6 generations on · 2010
Most influential descendants
Showing 5 of 24 · 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) | 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 | — |
| +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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | — | Simon Nitinol Filter/StraightlineTM System Named without a submission number | |
| * | — | Titanium Greenfield® Vena Cava Filter Named without a submission number |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 6 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 RecoveryTMFilter 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 anticoagulation 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/K022236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022236: Recovery Filter System, Model RF-048F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022236
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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