# K133243: Option Elite Vena Cava Filter System

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical, L.P.
- Decided: Dec 17, 2013 after 56 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K901502 (1990). 24 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081410: Option Vena Cava Filter, Rex Medical (2009) Summary page 1.

## Most influential descendants
- K143405: Option (TM) ELITE Vena Cava Filter 100cm System (2015), 1 descendant of its own
- K242612: Option ELITE Vena Cava Filter System (352506070E 352506100E) (2024), 0 descendants of its own

## Recalls of this device
- Sep 12, 2025 · Class II · Z-0589-2026: Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if exce
- Jun 8, 2023 · Class II · Z-2239-2023: There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

## Indications for use
The Option ELITE Vena Cava Filter System 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 anticoagulation 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/K133243
Methodology: https://510kreport.com/methodology