# K984496: Atrium Medical Corporation Express Chest Drain

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: May 5, 1999 after 139 days
- Product code: KDQ (Bottle, Collection, Vacuum)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K062302: Millicore AB Digivent Chest Drainage System (2006), 0 descendants of its own

## Recalls of this device
- Aug 26, 2021 · Class II · Z-2592-2021: The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
- Dec 23, 2016 · Class II · Z-1208-2017: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

## 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 collection of autologous blood from the patient’s pleural cavity or mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.

Source page: https://510kreport.com/device/K984496
Methodology: https://510kreport.com/methodology