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 Nov 3, 2016 as substantially equivalent to K122422 (Care Fusion, 2012) and 1 other predicate after a 260-day review. Its family tree reaches back 6 generations to 1993. 2 later devices descend from it.
- Decided
- Nov 3, 2016
- Review
- 260 days
- Class
- Class II
- Product code
- PNG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K932323 (1993). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 5 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- 4 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- 3 generations backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- 2 generations backK090394 Valved Tearway IntroducerMedcomp · 2009
- 1 generation backK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
- This deviceK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
- Descendant · cites it directly · 1 of its ownK201155 PleurX Peritoneal Catheter SystemCare Fusion · 2020
- Descendant · 2 generations on · 0 of its ownK241946 PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit…Bard Peripheral Vascular, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −5 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| −4 | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| −3 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| −2 | K090394 | Valved Tearway Introducer | Medcomp | 2009 | — |
| −1 | K122422 | Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved… | Care Fusion | 2012 | — |
| 0 (this device) | K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016 | — |
| +1 | K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020 | — |
| +2 | K241946 | PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™… | Bard Peripheral Vascular, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K122422 | Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Summary page 5…Class II per 21CFR §876.5630, Procode PNG Product Code(s) Multiple Legally marketed device(s) to CareFusion PleurX Catheter System: K122422, and which equivalence is claimed Bard Aspira Peritoneal Drainage System: K110396 This 510(k… | 2012 |
| * | K110396 | Aspira Peritoneal Drainage SystemSummary page 5…Multiple Legally marketed device(s) to CareFusion PleurX Catheter System: K122422, and which equivalence is claimed Bard Aspira Peritoneal Drainage System: K110396 This 510(k) submission is for a change in material formulation and Reason for 510(k) submission… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201155 | PleurX Peritoneal Catheter System | 2020 | 1 |
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 23 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K201155 (Care Fusion, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K122422.
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. 2016, 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, and for the palliation of symptoms related to recurrent malignant ascites. The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method. The PleurX Access…
Read the full statement (129 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, and for the palliation of symptoms related to recurrent malignant ascites.
The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The PleurX Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the PleurX Valve.
The PleurX LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.
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/K160437 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160437: PleurX Peritoneal Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160437
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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