510(k) Report

510(k) · Cleared

Cleared

Cordis Trapease Permanent Vena Cava Filter and Introduction Kit

K000062510(k) TraditionalCleared Jul 7, 2000179-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

Cordis Corp. · DTK Filter, Intravascular, Cardiovascular

Cleared on Jul 7, 2000 after a 179-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 15 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.

Decided
Jul 7, 2000
Review
179 days
Class
Class II
Product code
DTK
Recalls
None
Predicates
0

14 later devices descend from it, 3 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2002: 1 descendant cleared2004: 1 descendant cleared, 1 with a Class I recall12009: 1 descendant cleared2014: 1 descendant cleared2010: 1 descendant cleared, 1 with a Class I recall12017: 1 descendant cleared2013: 2 descendants cleared2012: 1 descendant cleared2024: 1 descendant cleared2015: 2 descendants cleared2018: 2 descendants cleared200020052010201520202025
  1. This deviceK000062 Cordis Trapease Permanent Vena Cava Filter and Introduction KitCordis Corp. · 2000
  2. Descendant · cites it directly · 6 of its ownK081410 Option Vena Cava FilterRex Medical · 2009
  3. Descendant · cites it directly · 6 of its ownK020316 Cordis Trapease Permanent Vena Cava Filter with the Visease…Cordis Corp. · 2002
  4. Descendant · cites it directly · 5 of its ownK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)
  5. Descendant · 2 generations on · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
  6. Descendant · 2 generations on · 2 of its ownK133243 Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12009: 12010: 12012: 12013: 22014: 12015: 22017: 12018: 22024: 1
2002high 2 (2013) · low 0 (2003)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 14 · See all
  • K081410Option Vena Cava FilterRex Medical · 2009 · cites it directly6descendants
  • K020316Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator…Cordis Corp. · 2002 · cites it directly6descendants
  • K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation · 2004 · cites it directly5descendants
  • K162875Sentry IVC filterNovate Medical, Ltd. · 2017 · 2 generations on2descendants
  • K133243Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000062Cordis Trapease Permanent Vena Cava Filter and Introduction KitCordis Corp.2000—
+1K081410Option Vena Cava FilterRex Medical2009—
+1K020316Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic…Cordis Corp.2002—
+1K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable…Cordis Corporation2004Class I
+2K162875Sentry IVC filterNovate Medical, Ltd.2017—
+2K133243Option Elite Vena Cava Filter SystemRex Medical, L.P.20132

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200411
200910
201011
201210
201320
201410
201520
201710
201820
202410
FIG. 1 — Lineage of K000062, 2000–2024Source: 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), 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. #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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K081410Option Vena Cava FilterRex Medical20096
K020316Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator…Cordis Corp.20026
K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter… Class ICordis Corporation20045

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, K081410 (Rex Medical, 2009) has gone furthest, with 6 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.

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—
Cite this page

510(k) Report. “K000062: Cordis Trapease Permanent Vena Cava Filter and Introduction Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000062

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026