510(k) · Cleared

Cleared

Option Vena Cava Filter

K081410510(k) TraditionalCleared Jun 4, 2009380-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

Rex Medical · DTK Filter, Intravascular, Cardiovascular

Cleared on Jun 4, 2009 as substantially equivalent to K964284 (Boston Scientific Corp, 1997) and 7 other predicates after a 380-day review. Its family tree reaches back 5 generations to 1990. 1 of the 30 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.

Decided: Jun 4, 2009
Review: 380 days
Class: Class II
Product code: DTK
Recalls: None
Predicates: 8

Its longest line of descent runs back 5 generations to K901502 (1990). 23 ancestors in all. 6 later devices descend from it, 2 citing it directly. 1 of the 30 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 5 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
4 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
3 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
2 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
1 generation backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
This deviceK081410 Option Vena Cava FilterRex Medical · 2009
Descendant · cites it directly · 2 of its ownK133243 Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · Recalled
Descendant · cites it directly · 2 of its ownK120402 Crux Vena Cava Filter SystemCrux Biomedical · 2012
Descendant · 2 generations on · 1 of its ownK143405 Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P. · 2015
Descendant · 2 generations on · 1 of its ownK122585 Crux Vena Cava Filter SystemCrux Biomedical · 2013
Descendant · 2 generations on · 0 of its ownK242612 Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012high 2 (2013) · low 0 (2014)2026

Class I recalls in this family

K970466 Radius Ptca Guidewire3 generations back · 1997

Most influential descendants

Showing 5 of 6 · See all

K133243Option Elite Vena Cava Filter SystemRex Medical, L.P. · 2013 · cites it directly2descendants
K120402Crux Vena Cava Filter SystemCrux Biomedical · 2012 · cites it directly2descendants
K143405Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P. · 2015 · 2 generations on1descendant
K122585Crux Vena Cava Filter SystemCrux Biomedical · 2013 · 2 generations on1descendant
K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K901502	Amplatz Goose-Neck Snare	Microvena Corp.	1990	1
−4	K972511	Amplatz Goose Neck Snare Kit/ Catheter	Microvena Corp.	1998	1
−3	K021441	Radius Snare	Radius Medical Technologies, Inc.	2002	—
−2	K022201	Radius Micro Snare	Radius Medical Technologies, Inc.	2003	—
−1	K032426	Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set	Cook, Inc.	2003	—
0 (this device)	K081410	Option Vena Cava Filter	Rex Medical	2009	—
+1	K133243	Option Elite Vena Cava Filter System	Rex Medical, L.P.	2013	2
+1	K120402	Crux Vena Cava Filter System	Crux Biomedical	2012	—
+2	K143405	Option (TM) ELITE Vena Cava Filter 100cm System	Rex Medical, L.P.	2015	—
+2	K122585	Crux Vena Cava Filter System	Crux Biomedical	2013	—
+2	K242612	Option ELITE Vena Cava Filter System (352506070E 352506100E)	Argon Medical Devices, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	2	0
1995	2	0
1996	1	0
1997	2	1
1998	1	0
2000	2	0
2002	2	0
2003	1	0
2005	2	0
2006	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	2	0
2015	2	0
2024	1	0

FIG. 1 — Lineage of K081410, 1990–2024Source: 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

Get a 510(k) Report

What was it cleared against? (8)

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
*	K964284	Stainless Steel Greenfield Vena Cava Filter with 12F Introducer System Summary page 1 …870.3375 Product Code: DTK Predicate Devices: Boston Scientific Corporation's SS Greenfield Vena Cava Filter - 1(964284, determined substantially equivalent on January 6,1997 (also 1K955396, 1K951508)…	Boston Scientific Corp	1997	3
*	K955396	Stainless Steel Greenfield Vena Cava Filter with 12F Flexcarrier Introducter System Summary page 1 …ation's SS Greenfield Vena Cava Filter - 1(964284, determined substantially equivalent on January 6,1997 (also 1K955396, 1K951508) Corclis Optease Vena Cava Filter - K(023116 determuined s…	Boston Scientific Corp	1996	—
*	K951508	Stainless Steel Greenfield Vena Cava Filter with 24F Introducer System Summary page 1 …Greenfield Vena Cava Filter - 1(964284, determined substantially equivalent on January 6,1997 (also 1K955396, 1K951508) Corclis Optease Vena Cava Filter - K(023116 determuined substantial…	Boston Scientific Corp	1995	—
*	K023116	Cordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200B Summary page 1 …ned substantially equivalent on January 6,1997 (also 1K955396, 1K951508) Corclis Optease Vena Cava Filter - K(023116 determuined substantially equivalent on October 18, 2002. Cordis Tra…	Cordis Corp.	2002	—
*	K000062	Cordis Trapease Permanent Vena Cava Filter and Introduction Kit Summary page 1 …er - K(023116 determuined substantially equivalent on October 18, 2002. Cordis Trapease Vena Cava Filter - 1(000062 determnined substantially equivalent on July 7, 2000 Bard Recovery Ve…	Cordis Corp.	2000	—
*	K022236	Recovery Filter System, Model RF-048F Summary page 1 …ava Filter - 1(000062 determnined substantially equivalent on July 7, 2000 Bard Recovery Vena Cava Filter - K(022236 determined substantially equivalent on November 27, 2002 Recovery G2…	C.R. Bard, Inc.	2002	—
*	K073090	Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain… Summary page 1 …y Vena Cava Filter - K(022236 determined substantially equivalent on November 27, 2002 Recovery G2 Filter - 1(073090 determined substantially equivalent on January 15, 2008 Gunther-Tuli…	C.R. Bard, Inc.	2008	—
*	K032426	Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set Summary page 1 …r - 1(073090 determined substantially equivalent on January 15, 2008 Gunther-Tulip Vena Cava Filter Set - 1(-032426 determined substantially equivalent on October 31, 2003. Device Description: The Rex Medi…	Cook, Inc.	2003	—

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K133243	Option Elite Vena Cava Filter System	Rex Medical, L.P.	2013	2
K120402	Crux Vena Cava Filter System	Crux Biomedical	2012	2

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 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
5 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K133243 (Rex Medical, L.P., 2013) has gone furthest, with 2 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. 2009, 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 Option* Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions: * Pulmonary thromboembolism when anticoagulant therapy is contraindicated; * Failure of anticoagulant therapy in thromboembolic diseases; * Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced; * Chronic, recurrent pulmonary embolism…

Read the full statement (106 words)

The Option* Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

* Pulmonary thromboembolism when anticoagulant therapy is contraindicated;

* Failure of anticoagulant therapy in thromboembolic diseases;

* Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced;

* Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated

The filter may be retrieved according to the instructions supplied in section entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081410 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081410: Option Vena Cava Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081410

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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