510(k) · Cleared
ClearedPleurx Peritoneal Catheter Kit and Pleurx Drainage Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denver Biomedical, Inc. · PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Cleared on Nov 15, 2005 after a 141-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.
- Decided
- Nov 15, 2005
- Review
- 141 days
- Class
- Class II
- Product code
- PNG
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 4 citing it directly.
- This deviceK051711 Pleurx Peritoneal Catheter Kit and Pleurx Drainage KitsDenver Biomedical, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK113854 Pleurx Peritoneal Catheter SystemCare Fusion · 2012
- Descendant · 2 generations on · 4 of its ownK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
- Descendant · cites it directly · 3 of its ownK152105 Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetRocket Medical Plc · 2016
- Descendant · cites it directly · 3 of its ownK093796 Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K113854Pleurx Peritoneal Catheter SystemCare Fusion · 2012 · cites it directly8descendants
- K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion · 2012 · 2 generations on4descendants
- K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetRocket Medical Plc · 2016 · cites it directly3descendants
- K093796Asept Peritoneal Drainage SystemPfm Medical, Inc. · 2010 · cites it directly3descendants
- K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051711 | Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits | Denver Biomedical, Inc. | 2005 | — |
| +1 | K113854 | Pleurx Peritoneal Catheter System | Care Fusion | 2012 | — |
| +2 | K122422 | Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved… | Care Fusion | 2012 | — |
| +1 | K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Rocket Medical Plc | 2016 | — |
| +1 | K093796 | Asept Peritoneal Drainage System | Pfm Medical, Inc. | 2010 | 1 |
| +3 | K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | — | Pleurx Catheter Named without a submission number |
What descends from it? (17)
See all 174 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?
- Of its descendants, K113854 (Care Fusion, 2012) has gone furthest, with 8 descendants of its own.
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.
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 Denver® Pleurx Peritoncal Catheter Kit (50-8000) is indicated for: Intermittent drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying diseasc Palliation of symptoms related to recurrent malignant ascites Peritoneal placcment only
The Denver® Pleurx Drainage Kits (50-7500 and 50-7510) are indicated for use with either the Pleurx Peritoneal Catheter Kit or the Pleurx Pleural Catheter Kit.
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/K051711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051711: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051711
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