# K081718: Express Chest Drain

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Jul 25, 2008 after 37 days
- Product code: KDQ (Bottle, Collection, Vacuum)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- May 7, 2015 · Class II · Z-1938-2015: Chest drains have a missing o-ring
- May 7, 2015 · Class II · Z-1936-2015: Chest drains have a missing o-ring
- May 7, 2015 · Class II · Z-1937-2015: Chest drains have a missing o-ring
- May 7, 2015 · Class II · Z-1935-2015: Chest drains have a missing o-ring

## Indications for use
To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

Source page: https://510kreport.com/device/K081718
Methodology: https://510kreport.com/methodology