510(k) Report

510(k) · Cleared

Cleared

Cook Celect and Gunther Tulip Vena Cava Filter Sets

K121057510(k) SpecialCleared May 4, 201228-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

William Cook Europe Aps · DTK Filter, Intravascular, Cardiovascular

Cleared on May 4, 2012 as substantially equivalent to K090140 (William Cook Europe Aps, 2009) after a 28-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.

Decided
May 4, 2012
Review
28 days
Class
Class II
Product code
DTK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K090140 (2009). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2012: 1 descendant clearedK090140 · Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter · William Cook Europe Aps · 200920052010201520202025
Descendants, by generation 1 generation forward: 2 descendants K090140 · Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter · William Cook Europe Aps · 20090
  1. Root · 1 generation backK090140 Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2009
  2. This deviceK121057 Cook Celect and Gunther Tulip Vena Cava Filter SetsWilliam Cook Europe Aps · 2012
  3. Descendant · cites it directly · 0 of its ownK172584 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2017
  4. Descendant · cites it directly · 0 of its ownK121629 Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook…William Cook Europe Aps · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…William Cook Europe Aps · 2017 · cites it directly0descendants
  • K121629Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena…William Cook Europe Aps · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K090140Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterWilliam Cook Europe Aps2009—
0 (this device)K121057Cook Celect and Gunther Tulip Vena Cava Filter SetsWilliam Cook Europe Aps2012—
+1K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip…William Cook Europe Aps2017—
+1K121629Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect…William Cook Europe Aps2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201710
FIG. 1 — Lineage of K121057, 2009–2017Source: 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.

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
*K090140Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter
Summary page 2
…ent pulmonary embolism. Predicate Devices: The Guinther Tulip Vena Cava Filter Sets are substantially equivalent to the predicate Gfinther Tulip Vena Cava Filter Sets.(K090 140). The Cook Celect Vena Cava Filter Sets are substantially equivalent to the predicate Cook Celect Vena Cava Filter Sets (K090 140…
William Cook Europe Aps2009—

Also cleared against K090140: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…William Cook Europe Aps20170
K121629Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena…William Cook Europe Aps20120

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?

  • Its one ancestor has no recall.
  • Of its descendants, K172584 (William Cook Europe Aps, 2017) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K090140.

How does its category compare?

All DTK devices

DTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Guinther Tulip Vena Cava Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: * Pulmonary thromboembolism when anticoagulant therapy is contraindicated; * Failure of anticoagulant therapy in thromboembolic diseases; * Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and * Chronic, recurrent PE where…

Read the full statement (247 words)

The Guinther Tulip Vena Cava Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

* Pulmonary thromboembolism when anticoagulant therapy is contraindicated;

* Failure of anticoagulant therapy in thromboembolic diseases;

* Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and

* Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Guinther Tulip Vena Cava Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Guinther Tulip Vena Cava Filter Retrieval Set (not included in the filter set).

The product is intended for percutaneous placement via a femoral vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Cook Celect Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

* Pulmonary thromboembolism when anticoagulant therapy is contraindicated;

* Failure of anticoagulant therapy in thromboembolic diseases;

* Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and

* Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Cook Celect Filter implant may be retrieved. Please refer to the Instructions for Use provided with the Guinther Tulip Vena Cava Filter Retrieval Set (not included in the filter set).

The product is intended for percutaneous placement via a femoral vein for filtration of inferior vena cava (IVC) blood to prevent pulmonary embolism.

Indications for use as stated in the FDA summary.

Also cleared against K090140

3 other devices cite the same predicate.

  • K172557Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular…William Cook Europe Aps · 20173 recalls
  • K113124Aln Optional Vana Cava FilterAln Implants Chirurgicaux · 2012
  • K121629Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena Cava Filter Set for…William Cook Europe Aps · 2012

More from William Cook Europe Aps

46 FDA decisions under this applicant name. See the company

  • P180001/S018Zenith Dissection Endovascular System (ZDEG/ZDES)William Cook Europe Aps · 2026
  • P180001/S017Zenith Fenestrated AAA Endovascular GraftWilliam Cook Europe Aps · 2026
  • P180001/S016Zenith Dissection Endovascular SystemWilliam Cook Europe Aps · 2026
  • K251596Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps · 2025
  • K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova…William Cook Europe Aps · 2025

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/K121057 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121057: Cook Celect and Gunther Tulip Vena Cava Filter Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121057

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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