# K163139: PleuraFlow System with FlowGlide

- Pathway: 510(k) (Special)
- Applicant: Clearflow, Inc.
- Decided: Nov 30, 2016 after 21 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: 4 generations back to K973703 (1997). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150042: PleuraFlow System, Clearflow, Inc. (2015) Summary page 5.

## Most influential descendants
- K191733: The ZIP Accessory Shuttle for PleuraFlow System (2019), 0 descendants of its own
- K182067: PleuraFlow System with FlowGlide Extra Drainage Length (2018), 0 descendants of its own

## Indications for use
The PleuraFlow® System with FlowGlide™ 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/K163139
Methodology: https://510kreport.com/methodology