# K241278: ASEPT® Glide Peritoneal Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Jan 14, 2025 after 253 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010642 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221779: ASEPT Peritoneal Drainage System, Pfm Medical, Inc. (2023) Summary page 5.

## Indications for use
The ASEPT Glide Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the ASEPT Glide Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for trans-jugular intrahepatic portosystemic shunt or LVP. The ASEPT Glide Peritoneal Catheter is indicated for adults only.

Source page: https://510kreport.com/device/K241278
Methodology: https://510kreport.com/methodology