510(k) · Decided
DecidedPleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer
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 Oct 24, 2012 as substantially equivalent to K113854 (Care Fusion, 2012) and 3 other predicates after a 76-day review. Its family tree reaches back 5 generations to 1993. 4 later devices descend from it.
- Decided
- Oct 24, 2012
- Review
- 76 days
- Class
- Class II
- Product code
- PNG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K932323 (1993). 13 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 4 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- 3 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- 2 generations backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- 1 generation backK090394 Valved Tearway IntroducerMedcomp · 2009
- This deviceK122422 Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx…Care Fusion · 2012
- Descendant · cites it directly · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
- Descendant · 2 generations on · 1 of its ownK201155 PleurX Peritoneal Catheter SystemCare Fusion · 2020
- Descendant · 3 generations on · 0 of its ownK241946 PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit…Bard Peripheral Vascular, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK170405 BD Curve Ascites ShuntCare Fusion · 2017
Most influential descendants
Showing 4 of 4 · See all- K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · cites it directly2descendants
- K201155PleurX Peritoneal Catheter SystemCare Fusion · 2020 · 2 generations on1descendant
- K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc. · 2024 · 3 generations on0descendants
- K170405BD Curve Ascites ShuntCare Fusion · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −4 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| −3 | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| −2 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| −1 | K090394 | Valved Tearway Introducer | Medcomp | 2009 | — |
| 0 (this device) | K122422 | Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved… | Care Fusion | 2012 | — |
| +1 | K160437 | PleurX Peritoneal Catheter System | Care Fusion | 2016 | — |
| +2 | K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020 | — |
| +3 | K241946 | PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™… | Bard Peripheral Vascular, Inc. | 2024 | — |
| +1 | K170405 | BD Curve Ascites Shunt | Care Fusion | 2017 | — |
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 |
|---|---|---|
| 2016 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K113854 | Pleurx Peritoneal Catheter SystemSummary page 4…ication panel Gastroenterology/Urology Regulation Class Il per 21CFR §876.5630, Procode PNG Product Code(s) Multiple Legally marketed CareFusion Pleurx Catheter Systems: K113854 device(s) to which Bard Aspira Pleural Drainage System: K110396 Martech (MEDCOMP) Valved Tearaway Introducer: K080394 Greatbatch… | 2012 |
| * | K110396 | Aspira Peritoneal Drainage SystemSummary page 4…1CFR §876.5630, Procode PNG Product Code(s) Multiple Legally marketed CareFusion Pleurx Catheter Systems: K113854 device(s) to which Bard Aspira Pleural Drainage System: K110396 Martech (MEDCOMP) Valved Tearaway Introducer: K080394 Greatbatch (MedAmicus) Incorporated FlowGuard Peelable Introducer; K040150… | 2011 |
| * | K090394 | Valved Tearway Introducer Our OCR of the scanned summary read K080394, FDA’s number for Blackstone Ascent Posterior Occipital Cervico-Thoracic… (Blackstone Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Martech (MEDCOMP) Valved Tearaway Introducer”. | 2009 |
| * | K040150 | Modification to Medamicus Flowguard Peelable IntroducerSummary page 4…ch Bard Aspira Pleural Drainage System: K110396 Martech (MEDCOMP) Valved Tearaway Introducer: K080394 Greatbatch (MedAmicus) Incorporated FlowGuard Peelable Introducer; K040150 Reason for 510(k) Expanding the indications for use and adding accessories. submission Device description The Pleurx Peritoneal… | 2004 |
What descends from it? (4)
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 19 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K160437 (Care Fusion, 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K113854.
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 (183 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 Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.
The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.
The Valved Peelable Introducers are intended for use in the percutaneous insertion of a 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/K122422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122422
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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