# K093307: Asept Pleural Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Nov 6, 2009 after 15 days
- Product code: DWM (Apparatus, Suction, Patient Care)
- Device class: 2
- Regulation: 21 CFR 870.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010642 (2001). 4 ancestors in all.
4 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)
- K010642: Pleurx Pleural Catheter and Drainage Kits, Denver Biomedicals, Inc. (2001) Summary page 1.
- K011831: Modification to Pleurx Pleural Catheter and Drainage Kits, Denver Biomedical, Inc. (2001) Summary page 1.
- K051084: Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line, Denver Biomedicals, Inc. (2005) Summary page 1.
- K052436: Pleurx Pleural Catheter Kit, Model 50-7000, Denver Biomedical, Inc. (2005) Summary page 1.

## Most influential descendants
- K093796: Asept Peritoneal Drainage System (2010), 3 descendants of its own
- K221779: ASEPT Peritoneal Drainage System (2023), 1 descendant of its own
- K241278: ASEPT® Glide Peritoneal Drainage System (2025), 0 descendants of its own
- K113354: Veta Peritoneal Dialysis Catheter (2012), 0 descendants of its own

## Recalls of this device
- Oct 20, 2014 · Class II · Z-0561-2015: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- Oct 20, 2014 · Class II · Z-0562-2015: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

## Indications for use
The Asept Pleural Drainage System is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions, including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.

Source page: https://510kreport.com/device/K093307
Methodology: https://510kreport.com/methodology