# K062302: Millicore AB Digivent Chest Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Millicore AB
- Decided: Oct 6, 2006 after 59 days
- Product code: KDQ (Bottle, Collection, Vacuum)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801043 (1980). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984496: Atrium Medical Corporation Express Chest Drain, Atrium Medical Corp. (1999) Summary page 1.
- K962856: Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 Autotr, Deknatel, Inc. (1996) Summary page 1.

## Indications for use
The DigiVent TM Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.

Source page: https://510kreport.com/device/K062302
Methodology: https://510kreport.com/methodology