# K182067: PleuraFlow System with FlowGlide Extra Drainage Length

- Pathway: 510(k) (Special)
- Applicant: Clearflow, Inc.
- Decided: Aug 14, 2018 after 13 days
- Product code: OTK (Wound Drain Catheter System)
- Device class: 2
- Regulation: 21 CFR 878.4780
- 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 K973703 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163139: PleuraFlow System with FlowGlide, Clearflow, Inc. (2016) Summary page 5.

## Indications for use
The PleuraFlow® System with FlowGlide® XDL is indicated for use during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology® proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.

Source page: https://510kreport.com/device/K182067
Methodology: https://510kreport.com/methodology