510(k) · Decided
DecidedPleurx Peritoneal Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Cleared on Mar 19, 2012 as substantially equivalent to K051711 (Denver Biomedical, Inc., 2005) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 2008. 8 later devices descend from it.
- Decided
- Mar 19, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- PNG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K081288 (2008). 3 ancestors in all, the oldest K051711 (2005). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK081288 Aspira Peritoneal Drainage SystemC.R. Bard, Inc. · 2008
- 1 generation backK110396 Aspira Peritoneal Drainage SystemC.R. Bard, Inc. · 2011 · Recalled
- This deviceK113854 Pleurx Peritoneal Catheter SystemCare Fusion · 2012
- Descendant · cites it directly · 4 of its ownK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
- Descendant · 2 generations on · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
- Descendant · cites it directly · 2 of its ownK121849 Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx…Care Fusion · 2012
- Descendant · 3 generations on · 1 of its ownK201155 PleurX Peritoneal Catheter SystemCare Fusion · 2020
- Descendant · 2 generations on · 1 of its ownK141965 Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion · 2012 · cites it directly4descendants
- K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · 2 generations on2descendants
- K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion · 2012 · cites it directly2descendants
- K201155PleurX Peritoneal Catheter SystemCare Fusion · 2020 · 3 generations on1descendant
- K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081288 | Aspira Peritoneal Drainage System | C.R. Bard, Inc. | 2008 | — |
| −1 | K110396 | Aspira Peritoneal Drainage System | C.R. Bard, Inc. | 2011 | 17 |
| 0 (this device) | K113854 | Pleurx Peritoneal Catheter System | Care Fusion | 2012 | — |
| +1 | K122422 | Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved… | Care Fusion | 2012 | — |
| +2 | K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016 | — |
| +1 | K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter… | Care Fusion | 2012 | — |
| +3 | K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020 | — |
| +2 | K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit | Care Fusion | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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…gy/Urology Regulation Class Il per 21CFR §876.5630, Procode FJS Product Code(s) Muttiple Legally marketed CareFusion Pleurx Peritoneal Catheter Kit and Drainage Kits: K051711 device(s) to which equivalence is claimed Bard Aspira Periloneal Drainage System: K110396 Device description The Pieurx Periton… | 2005 |
| * | K110396 | Aspira Peritoneal Drainage SystemSummary page 4…Legally marketed CareFusion Pleurx Peritoneal Catheter Kit and Drainage Kits: K051711 device(s) to which equivalence is claimed Bard Aspira Periloneal Drainage System: K110396 Device description The Pieurx Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascite… | 2011 |
What descends from it? (8)
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)
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 4 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K122422 (Care Fusion, 2012) has gone furthest, with 4 descendants 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. 2012, 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 Pleurx Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only. The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleurx Pleural Catheter for…
Read the full statement (145 words)
The Pleurx Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only.
The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleurx Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.
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/K113854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113854: Pleurx Peritoneal Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113854
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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