510(k) · Cleared
ClearedASEPT® Glide Peritoneal Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfm Medical, Inc. · PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Cleared on Jan 14, 2025 as substantially equivalent to K221779 (Pfm Medical, Inc., 2023) after a 253-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jan 14, 2025
- Review
- 253 days
- Class
- Class II
- Product code
- PNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010642 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK010642 Pleurx Pleural Catheter and Drainage KitsDenver Biomedicals, Inc. · 2001
- 3 generations backK093307 Asept Pleural Drainage SystemPfm Medical, Inc. · 2009 · Recalled
- 2 generations backK093796 Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010 · Recalled
- 1 generation backK221779 ASEPT Peritoneal Drainage SystemPfm Medical, Inc. · 2023
- This deviceK241278 ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010642 | Pleurx Pleural Catheter and Drainage Kits | Denver Biomedicals, Inc. | 2001 | — |
| −3 | K093307 | Asept Pleural Drainage System | Pfm Medical, Inc. | 2009 | 2 |
| −2 | K093796 | Asept Peritoneal Drainage System | Pfm Medical, Inc. | 2010 | 1 |
| −1 | K221779 | ASEPT Peritoneal Drainage System | Pfm Medical, Inc. | 2023 | — |
| 0 (this device) | K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PNG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PNG device
- #1 K241946 PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L…score 10.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221779 | ASEPT Peritoneal Drainage SystemSummary page 5…I. LEGALLY MARGETED PREDICATE DEVICES Predicate Device 510(k) Product Name Clearance Date K221779 ASEPT Peritoneal Drainage System May 02, 2023… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All PNG devicesPNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PNG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNG
244in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNG
No recall names PNG since 2007.
Adverse event reports per year · PNG
31in 2025
MAUDE reports naming product code PNG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | 244 | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 2 | — | 0 | 21 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 31 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241278: ASEPT® Glide Peritoneal Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241278
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026