# K081410: Option Vena Cava Filter

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical
- Decided: Jun 4, 2009 after 380 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K901502 (1990). 23 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964284: Stainless Steel Greenfield Vena Cava Filter with 12F Introducer System, Boston Scientific Corp (1997) Summary page 1.
- K955396: Stainless Steel Greenfield Vena Cava Filter with 12F Flexcarrier Introducter System, Boston Scientific Corp (1996) Summary page 1.
- K951508: Stainless Steel Greenfield Vena Cava Filter with 24F Introducer System, Boston Scientific Corp (1995) Summary page 1.
- K023116: Cordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200B, Cordis Corp. (2002) Summary page 1.
- K000062: Cordis Trapease Permanent Vena Cava Filter and Introduction Kit, Cordis Corp. (2000) Summary page 1.
- K022236: Recovery Filter System, Model RF-048F, C.R. Bard, Inc. (2002) Summary page 1.
- K073090: Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/Subclavain Delivery Kit, Model RF-320J, C.R. Bard, Inc. (2008) Summary page 1.
- K032426: Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set, Cook, Inc. (2003) Summary page 1.

## Most influential descendants
- K133243: Option Elite Vena Cava Filter System (2013), 2 descendants of its own
- K120402: Crux Vena Cava Filter System (2012), 2 descendants of its own
- K143405: Option (TM) ELITE Vena Cava Filter 100cm System (2015), 1 descendant of its own
- K122585: Crux Vena Cava Filter System (2013), 1 descendant of its own
- K242612: Option ELITE Vena Cava Filter System (352506070E 352506100E) (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K081410
Methodology: https://510kreport.com/methodology