510(k) · Cleared

Cleared

Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena Cava Filter Set for Jugular Appr

K121629510(k) TraditionalCleared Jul 3, 201229-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 Jul 3, 2012 as substantially equivalent to K073374 (William Cook Europe Aps, 2008) and 2 other predicates after a 29-day review. Its family tree reaches back 6 generations to 1990. 1 of the 16 devices in its family, counting itself, has a Class I recall.

Decided: Jul 3, 2012
Review: 29 days
Class: Class II
Product code: DTK
Recalls: None
Predicates: 3

Its longest line of descent runs back 6 generations to K901502 (1990). 15 ancestors in all. No later device cites it as a predicate yet. 1 of the 16 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 6 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
5 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
4 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
3 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
2 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
1 generation backK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
This deviceK121629 Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook…William Cook Europe Aps · 2012

Class I recalls in this family

K970466 Radius Ptca Guidewire4 generations back · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K901502	Amplatz Goose-Neck Snare	Microvena Corp.	1990	1
−5	K972511	Amplatz Goose Neck Snare Kit/ Catheter	Microvena Corp.	1998	1
−4	K021441	Radius Snare	Radius Medical Technologies, Inc.	2002	—
−3	K022201	Radius Micro Snare	Radius Medical Technologies, Inc.	2003	—
−2	K032426	Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set	Cook, Inc.	2003	—
−1	K073374	Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set	William Cook Europe Aps	2008	—
0 (this device)	K121629	Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect…	William Cook Europe Aps	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	2	0
1997	1	1
1998	1	0
2000	1	0
2007	1	0
2009	1	0
2012	1	0

FIG. 1 — Lineage of K121629, 1990–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K073374	Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set Summary page 2 …pulmonary embolism. Predicate Devices: The Cook Celect Platinum Vena Cava Filter Sets are substantially equivalent to the predicate Cook Celect Vena Cava Filter Sets (K073374, K090140, K121057). The femoral introducer is identical to the femoral introducer of the predicate Cook Celect Vena Cava Filter S…	William Cook Europe Aps	2008	—
*	K090140	Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter Summary page 2 …y embolism. Predicate Devices: The Cook Celect Platinum Vena Cava Filter Sets are substantially equivalent to the predicate Cook Celect Vena Cava Filter Sets (K073374, K090140, K121057). The femoral introducer is identical to the femoral introducer of the predicate Cook Celect Vena Cava Filter Set with F…	William Cook Europe Aps	2009	—
*	K121057	Cook Celect and Gunther Tulip Vena Cava Filter Sets Summary page 2 …m. Predicate Devices: The Cook Celect Platinum Vena Cava Filter Sets are substantially equivalent to the predicate Cook Celect Vena Cava Filter Sets (K073374, K090140, K121057). The femoral introducer is identical to the femoral introducer of the predicate Cook Celect Vena Cava Filter Set with Flexible T…	William Cook Europe Aps	2012	—

Also cleared against K073374: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.

K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
3 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
5 other devices also cite its predicate K073374.

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

2007high 6 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTK

29in 2024

2007high 380 (2009) · low 29 (2024)2026

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

Recalls per year · DTK

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	87	1	364
2008	6	87	0	345
2009	3	380	0	456
2010	3	50	0	369
2011	2	—	0	439
2012	5	156	0	351
2013	3	91	1	473
2014	2	—	0	451
2015	2	—	1	859
2016	3	84	2	2,574
2017	5	88	0	4,364
2018	2	—	0	3,938
2019	0	—	6	6,467
2020	0	—	0	5,405
2021	2	—	0	5,357
2022	0	—	2	2,191
2023	0	—	0	583
2024	5	29	0	406
2025	0	—	1	432
2026	0	—	0	—

What is it indicated for?

The Cook Celect Platinum 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 (126 words)

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

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121629 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121629: Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena Cava Filter Set for Jugular Appr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121629

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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