510(k) Report

510(k) · Cleared

Cleared

Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain Delivery Kit, Model RF-320J

K073090510(k) TraditionalCleared Jan 15, 200875-day reviewClass II21 CFR 870.3375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · DTK Filter, Intravascular, Cardiovascular

Cleared on Jan 15, 2008 as substantially equivalent to K062887 (Bard Peripheral Vascular, 2006) and 1 other predicate after a 75-day review. Its family tree reaches back 3 generations to 2002. 1 of the 26 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.

Decided
Jan 15, 2008
Review
75 days
Class
Class II
Product code
DTK
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K022236 (2002). 5 ancestors in all. 20 later devices descend from it, 2 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2009: 1 descendant cleared2008: 2 descendants cleared2013: 3 descendants cleared2012: 1 descendant cleared2010: 3 descendants cleared, 1 with a Class I recall12024: 2 descendants cleared2015: 2 descendants cleared2014: 2 descendants cleared2016: 2 descendants cleared2011: 2 descendants clearedK022236 · Recovery Filter System, Model RF-048F · C.R. Bard, Inc. · 2002×2: 2 generations cleared close together, K050558 (2005), K052578 (2005) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants, 1 with a Class I recall14 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant K052578 · Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J · Bard Peripheral Vascular, Inc. · 2005 · recalledK050558 · Modification to: Recovery Filter System, Model RF-210F · C.R. Bard, Inc. · 2005K022236 · Recovery Filter System, Model RF-048F · C.R. Bard, Inc. · 20020+5
  1. Root · 3 generations backK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
  2. 2 generations backK050558 Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005
  3. 1 generation backK052578 Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · Recalled
  4. This deviceK073090 Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc. · 2008
  5. Descendant · cites it directly · 12 of its ownK080668 G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian…C.R. Bard, Inc. · 2008
  6. Descendant · 2 generations on · 11 of its ownK082305 G2 Express Filter System - Femoral and Jugular/Subclavian Delivery…C.R. Bard, Inc. · 2008
  7. Descendant · 3 generations on · 8 of its ownK093659 Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter…C.R. Bard, Inc. · 2010
  8. Descendant · 4 generations on · 6 of its ownK101431 Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010
  9. Descendant · cites it directly · 6 of its ownK081410 Option Vena Cava FilterRex Medical · 2009

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2008: 22009: 12010: 32011: 22012: 12013: 32014: 22015: 22016: 22024: 2
2008high 3 (2010) · low 0 (2017)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 20 · See all
  • K080668G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery KitsC.R. Bard, Inc. · 2008 · cites it directly12descendants
  • K082305G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2008 · 2 generations on11descendants
  • K093659Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian…C.R. Bard, Inc. · 2010 · 3 generations on8descendants
  • K101431Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010 · 4 generations on6descendants
  • K081410Option Vena Cava FilterRex Medical · 2009 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K022236Recovery Filter System, Model RF-048FC.R. Bard, Inc.2002—
−2K050558Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc.2005—
−1K052578Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc.20052
0 (this device)K073090Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc.2008—
+1K080668G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J)…C.R. Bard, Inc.2008—
+2K082305G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc.2008—
+3K093659Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter…C.R. Bard, Inc.2010—
+4K101431Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc.2010—
+1K081410Option Vena Cava FilterRex Medical2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200910
201031
201120
201210
201330
201420
201520
201620
202420
FIG. 1 — Lineage of K073090, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K062887Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310F
Summary page 1
…vascular Classification: Class II Classification Panel: Cardiovascular 3. Predicate Devices: G2TM Filter System - Femoral Delivery Kit (K062887) G2TM Filter System - Jugular/Subclavian Delivery Kit (K052578) Traditional 510(k) Recovery® G2 Filter System -…
Bard Peripheral Vascular2006—
*K052578Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320J
Summary page 1
…ation Panel: Cardiovascular 3. Predicate Devices: G2TM Filter System - Femoral Delivery Kit (K062887) G2TM Filter System - Jugular/Subclavian Delivery Kit (K052578) Traditional 510(k) Recovery® G2 Filter System - Femoral and Jugular/Subclavian Delivery Kits Page 137…
Bard Peripheral Vascular, Inc.20052

What descends from it? (20)

See all 20

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080668G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery KitsC.R. Bard, Inc.200812
K081410Option Vena Cava FilterRex Medical20096

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 · 3 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 5 ancestors has a recall of any class.
  • Of its descendants, K080668 (C.R. Bard, Inc., 2008) has gone furthest, with 12 descendants of its own.

How does its category compare?

All DTK devices

DTK 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

2007: 32008: 62009: 32010: 32011: 22012: 52013: 32014: 22015: 22016: 32017: 52018: 22021: 22024: 5
2007high 6 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTK

29in 2024

2007: 87 days median2008: 87 days median2009: 380 days median2010: 50 days median2012: 156 days median2013: 91 days median2016: 84 days median2017: 88 days median2024: 29 days median
2007high 380 (2009) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTK

1in 2025

2007: 12013: 12015: 12016: 22019: 62022: 22025: 1
2007high 6 (2019) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTK

432in 2025

2007: 3642008: 3452009: 4562010: 3692011: 4392012: 3512013: 4732014: 4512015: 8592016: 2,5742017: 4,3642018: 3,9382019: 6,4672020: 5,4052021: 5,3572022: 2,1912023: 5832024: 4062025: 432
2007high 6,467 (2019) · low 345 (2008)2025

MAUDE reports naming product code DTK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073871364
20086870345
200933800456
20103500369
20112—0439
201251560351
20133911473
20142—0451
20152—1859
201638422,574
201758804,364
20182—03,938
20190—66,467
20200—05,405
20212—05,357
20220—22,191
20230—0583
20245290406
20250—1432
20260—0—

What is it indicated for?

The Recovery® G2® 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 (92 words)

The Recovery® G2® 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.

Recovery® G2® 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.

Cite this page

510(k) Report. “K073090: Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain Delivery Kit, Model RF-320J.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073090

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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