510(k) Report

510(k) · Cleared

Cleared

Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian Delivery Kit Model RF500F Model RF5

K093659510(k) SpecialCleared Jan 14, 201050-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 14, 2010 as substantially equivalent to K082305 (C.R. Bard, Inc., 2008) after a 50-day review. Its family tree reaches back 6 generations to 2002. 8 later devices descend from it.

Decided
Jan 14, 2010
Review
50 days
Class
Class II
Product code
DTK
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K022236 (2002). 8 ancestors in all. 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2010: 1 descendant cleared2016: 2 descendants cleared2011: 2 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2024: 1 descendant clearedK022236 · Recovery Filter System, Model RF-048F · C.R. Bard, Inc. · 2002×2: 2 generations cleared close together, K050558 (2005), K052578 (2005) K073090 · Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain Delivery Kit, Model RF-320J · C.R. Bard, Inc. · 2008×2: 2 generations cleared close together, K080668 (2008), K082305 (2008) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 4 generations back: 1 other ancestor6 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K082305 · G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits · C.R. Bard, Inc. · 2008K080668 · G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery Kits · C.R. Bard, Inc. · 2008K073090 · Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain Delivery Kit, Model RF-320J · C.R. Bard, Inc. · 2008K052578 · 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. · 2002−50+5
  1. Root · 6 generations backK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
  2. 5 generations backK050558 Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005
  3. 4 generations backK052578 Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · Recalled
  4. 3 generations backK073090 Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc. · 2008
  5. 2 generations backK080668 G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian…C.R. Bard, Inc. · 2008
  6. 1 generation backK082305 G2 Express Filter System - Femoral and Jugular/Subclavian Delivery…C.R. Bard, Inc. · 2008
  7. This deviceK093659 Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter…C.R. Bard, Inc. · 2010
  8. Descendant · cites it directly · 6 of its ownK101431 Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010
  9. Descendant · 2 generations on · 3 of its ownK130366 Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery…C.R. Bard, Inc. · 2013 · Recalled
  10. Descendant · 3 generations on · 2 of its ownK143208 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2014
  11. Descendant · 4 generations on · 1 of its ownK160866 Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc. · 2016
  12. Descendant · 2 generations on · 1 of its ownK102511 Meridan Filter System- Jungular/Subeclavian Delivery KitC.R. Bard, Inc. · 2011

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22013: 12014: 12016: 22024: 1
2010high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 8 · See all
  • K101431Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2010 · cites it directly6descendants
  • K130366Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery KitC.R. Bard, Inc. · 2013 · 2 generations on3descendants
  • K143208Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain…C.R. Bard, Inc. · 2014 · 3 generations on2descendants
  • K160866Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian…C.R. Bard, Inc. · 2016 · 4 generations on1descendant
  • K102511Meridan Filter System- Jungular/Subeclavian Delivery KitC.R. Bard, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K022236Recovery Filter System, Model RF-048FC.R. Bard, Inc.2002—
−5K050558Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc.2005—
−4K052578Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc.20052
−3K073090Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc.2008—
−2K080668G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J)…C.R. Bard, Inc.2008—
−1K082305G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc.2008—
0 (this device)K093659Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter…C.R. Bard, Inc.2010—
+1K101431Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc.2010—
+2K130366Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery KitC.R. Bard, Inc.20133
+3K143208Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc.2014—
+4K160866Denali Filter System - Femoral Delivery Kit, Denali Filter System -…C.R. Bard, Inc.2016—
+2K102511Meridan Filter System- Jungular/Subeclavian Delivery KitC.R. Bard, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201310
201410
201620
202410
FIG. 1 — Lineage of K093659, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in DTK? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K082305G2 Express Filter System - Femoral and Jugular/Subclavian Delivery Kits
Summary page 1
…ation: Class 11 Classification Panel: Cardiovascular Predicate Devices: G2 EXPRESS® Filter System - Femoral Delivery Kits (K082305) G2 EXPRESS® Fihter System -Jugular/Subclavian Delivery Kits (K082305) TRADE S…
C.R. Bard, Inc.2008—

Also cleared against K082305: 1 other device →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K101431Eclipse Filter System-Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc.20106
K160747Angel CatheterBio2 Medical, Inc.20160

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K101431 (C.R. Bard, Inc., 2010) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K082305.

How does its category compare?

All DTK devices

DTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ECLIPSETh 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 thramboembolism 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 (95 words)

The ECLIPSETh 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 thramboembolism 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.

• ECLIPSETm 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.

Also cleared against K082305

1 other device cites the same predicate.

  • K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 20101 Class I recall

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

Recent decisions in DTK

The DTK category page

  • K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. · 2024
  • K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc. · 2024
  • K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L. · 2024
  • K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBd · 2024
  • K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum…William Cook Europe Aps · 2024

https://510kreport.com/device/K093659 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093659: Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian Delivery Kit Model RF500F Model RF5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093659

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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