510(k) Report

510(k) · Decided

Decided

Modification to: Recovery Filter System, Model RF-210F

K050558510(k) TraditionalDecided Aug 29, 2005179-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 Aug 29, 2005 as substantially equivalent to K022236 (C.R. Bard, Inc., 2002) and 1 other predicate after a 179-day review. Its family tree reaches back 1 generation to 2002. 1 of the 26 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.

Decided
Aug 29, 2005
Review
179 days
Class
Class II
Product code
DTK
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K022236 (2002). 2 ancestors in all. 23 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 2003: 1 other ancestor2006: 1 descendant cleared2005: 1 descendant cleared2008: 3 descendants cleared2009: 1 descendant 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. · 2002200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 5 descendants, 1 with a Class I recall16 generations forward: 4 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant10 generations forward: 1 descendant K022236 · Recovery Filter System, Model RF-048F · C.R. Bard, Inc. · 20020+5+10
  1. Root · 1 generation backK022236 Recovery Filter System, Model RF-048FC.R. Bard, Inc. · 2002
  2. This deviceK050558 Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc. · 2005
  3. Descendant · cites it directly · 21 of its ownK062887 Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FBard Peripheral Vascular · 2006
  4. Descendant · cites it directly · 21 of its ownK052578 Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · Recalled
  5. Descendant · 2 generations on · 20 of its ownK073090 Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc. · 2008
  6. Descendant · 3 generations on · 12 of its ownK080668 G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian…C.R. Bard, Inc. · 2008
  7. Descendant · 4 generations on · 11 of its ownK082305 G2 Express Filter System - Femoral and Jugular/Subclavian Delivery…C.R. Bard, Inc. · 2008

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 32009: 12010: 32011: 22012: 12013: 32014: 22015: 22016: 22024: 2
2005high 3 (2008) · low 0 (2007)2026

Class I recalls in this family

  • K091077 Optease Vena Cava Filter and Retrieval Catheter5 generations on · 2010

Most influential descendants

Showing 5 of 23 · See all
  • K062887Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FBard Peripheral Vascular · 2006 · cites it directly21descendants
  • K052578Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. · 2005 · cites it directly21descendants
  • K073090Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain…C.R. Bard, Inc. · 2008 · 2 generations on20descendants
  • K080668G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J) Delivery KitsC.R. Bard, Inc. · 2008 · 3 generations on12descendants
  • K082305G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc. · 2008 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022236Recovery Filter System, Model RF-048FC.R. Bard, Inc.2002—
0 (this device)K050558Modification to: Recovery Filter System, Model RF-210FC.R. Bard, Inc.2005—
+1K062887Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FBard Peripheral Vascular2006—
+1K052578Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc.20052
+2K073090Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F…C.R. Bard, Inc.2008—
+3K080668G2 Express Filter System-Femoral (RF400F) and Jugular/Subclavian (RF400J)…C.R. Bard, Inc.2008—
+4K082305G2 Express Filter System - Femoral and Jugular/Subclavian Delivery KitsC.R. Bard, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200830
200910
201031
201120
201210
201330
201420
201520
201620
202420
FIG. 1 — Lineage of K050558, 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
*K022236Recovery Filter System, Model RF-048F
Summary page 1
…rements for Cardiac and Vascular Implants - Part 3: Endovascular Devices". C. Predicate Device Device Name(s): Recovery Filter System (K022236, cleared 11/27/02) Classification: Class IIwith Special Controls Bard Peripheral Vascular, Inc TRAD…
C.R. Bard, Inc.2002—
*K031328Recovery Filter System, Model RF-048F
Summary page 3
…Substantial Equivalence: The subject device has the following similarities to the predicate device that received clearance to market via K022236 on 11/27/02 and K031328 on 07/25/03: - Same intended use; - Same filter and delivery system materials; - Same operating principle; - Same…
C.R. Bard, Inc.2003—

Also cleared against K022236: 1 other device →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K062887Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FBard Peripheral Vascular200621
K052578Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc.200521

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 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K062887 (Bard Peripheral Vascular, 2006) has gone furthest, with 21 descendants of its own.
  • 1 other device also cites its predicate K022236.

How does its category compare?

All DTK devices

DTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 G2 Filter 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.

Also cleared against K022236

1 other device cites the same predicate.

  • K081410Option Vena Cava FilterRex Medical · 2009

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/K050558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050558: Modification to: Recovery Filter System, Model RF-210F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050558

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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