# K093565: Pleuraflow Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Clear Catheter Systems
- Decided: Dec 3, 2010 after 380 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: 2 generations back to K973703 (1997). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052286: Deutsch Anti-Blockage Wound Drain, The Catheter Exchange, Inc. (2005) Summary page 1.

## Most influential descendants
- K150042: PleuraFlow System (2015), 4 descendants of its own
- K163139: PleuraFlow System with FlowGlide (2016), 2 descendants of its own
- 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
- K153681: PleuraFlow System (2016), 0 descendants of its own

## Indications for use
The PleuraFlow Catheter is indicated for use as an adjunctive device during open Surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.

Source page: https://510kreport.com/device/K093565
Methodology: https://510kreport.com/methodology