# K093796: Asept Peritoneal Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Feb 26, 2010 after 77 days
- Product code: PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010642 (2001). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051711: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits, Denver Biomedical, Inc. (2005) Summary page 4.
- K093307: Asept Pleural Drainage System, Pfm Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- 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-0568-2015: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

## Indications for use
The Asept Peritoneal Drainage System is indicated for periodic drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long term access of the peritoneal cavity in order to relieve symptoms such as dyspnea.

Source page: https://510kreport.com/device/K093796
Methodology: https://510kreport.com/methodology