510(k) · Decided
Recalled · Class II · 2014Asept 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 Feb 26, 2010 as substantially equivalent to K051711 (Denver Biomedical, Inc., 2005) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 26, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- PNG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010642 (2001). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010642 Pleurx Pleural Catheter and Drainage KitsDenver Biomedicals, Inc. · 2001
- 1 generation backK093307 Asept Pleural Drainage SystemPfm Medical, Inc. · 2009 · Recalled
- This deviceK093796 Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK221779 ASEPT Peritoneal Drainage SystemPfm Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK241278 ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK113354 Veta Peritoneal Dialysis CatheterPfm Medical, Inc. · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010642 | Pleurx Pleural Catheter and Drainage Kits | Denver Biomedicals, Inc. | 2001 | — |
| −1 | K093307 | Asept Pleural Drainage System | Pfm Medical, Inc. | 2009 | 2 |
| 0 (this device) | K093796 | Asept Peritoneal Drainage System | Pfm Medical, Inc. | 2010 | — |
| +1 | K221779 | ASEPT Peritoneal Drainage System | Pfm Medical, Inc. | 2023 | — |
| +2 | K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | 2025 | — |
| +1 | K113354 | Veta Peritoneal Dialysis Catheter | Pfm Medical, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K051711 | Pleurx Peritoneal Catheter Kit and Pleurx Drainage KitsSummary page 4…ries Classification: FJS Equivalent Devices: Manufacturer: Denver Biomedical (Cardinal Health) Name: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits 510(k) #: K051711 Manufacturer: PFM Medical Name: Asept Pleural Drainage System 510(k) #: K093307 Device Description: The Asept Peritoneal Dra… | 2005 |
| * | K093307 | Asept Pleural Drainage SystemSummary page 4…dinal Health) Name: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits 510(k) #: K051711 Manufacturer: PFM Medical Name: Asept Pleural Drainage System 510(k) #: K093307 Device Description: The Asept Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid fro… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2014 | Class II | Z-0568-2015 | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K221779 (Pfm Medical, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K051711.
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. 2010, 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 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.
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/K093796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093796: Asept 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/K093796
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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