510(k) · Cleared
Recalled · Class II · 2023Aspira Peritoneal Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Cleared on May 6, 2011 as substantially equivalent to K081288 (C.R. Bard, Inc., 2008) after an 84-day review. Its family tree reaches back 1 generation to 2008. 10 later devices descend from it. It has been recalled 17 times.
- Decided
- May 6, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- PNG
- Recalls
- 17
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081288 (2008). 10 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK081288 Aspira Peritoneal Drainage SystemC.R. Bard, Inc. · 2008
- This deviceK110396 Aspira Peritoneal Drainage SystemC.R. Bard, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK113854 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 · cites it directly · 2 of its ownK160437 PleurX Peritoneal Catheter SystemCare Fusion · 2016
- Descendant · 2 generations on · 2 of its ownK121849 Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx…Care Fusion · 2012
- Descendant · 2 generations on · 1 of its ownK201155 PleurX Peritoneal Catheter SystemCare Fusion · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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 · cites it directly4descendants
- K160437PleurX Peritoneal Catheter SystemCare Fusion · 2016 · cites it directly2descendants
- K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion · 2012 · 2 generations on2descendants
- K201155PleurX Peritoneal Catheter SystemCare Fusion · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081288 | Aspira Peritoneal Drainage System | C.R. Bard, Inc. | 2008 | — |
| 0 (this device) | K110396 | Aspira Peritoneal Drainage System | C.R. Bard, Inc. | 2011 | — |
| +1 | K113854 | Pleurx Peritoneal Catheter System | Care Fusion | 2012 | — |
| +1 | 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 | K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter… | Care Fusion | 2012 | — |
| +2 | K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K081288 | Aspira Peritoneal Drainage SystemSummary page 4…ice ’ Classification Name: Peritoneal Dialysis System and Accessories 21 CFR 876.5630 - Class Il FJS - Peritoneal dialysis system and accessories Premarket Notification: K081288, concumrence date 18 July 2008 Manufacturer. - Bard Access Systems, Inc. Device The Aspira* Peritoneal Drainage System provides p… | 2008 |
What descends from it? (10)
4 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 |
|---|---|---|---|---|
| Apr 22, 2023 | Class II | Z-1915-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1911-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1913-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1916-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1912-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1920-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1918-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1914-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1909-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1910-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1917-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1908-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| Apr 22, 2023 | Class II | Z-1919-2023 | Process control | There is a potential that valve assemblies will not open. preventing fluid from draining. |
| May 21, 2011 | Not classified | Z-2962-2011 | Error in labeling | Labeling for drainage kit contained incomplete information. |
| May 21, 2011 | Not classified | Z-2959-2011 | Error in labeling | Labeling for drainage kit contained incomplete information. |
| May 21, 2011 | Not classified | Z-2961-2011 | Error in labeling | Labeling for drainage kit contained incomplete information. |
| May 21, 2011 | Not classified | Z-2960-2011 | Error in labeling | Labeling for drainage kit contained incomplete information. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 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. 2011, 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 Aspira® Peritoneal Drainage System is indicated for intermittent 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 or other symptoms associated with malignant ascites. The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage. The Aspira® Dressing Kit is indicated for dressing…
Read the full statement (139 words)
The Aspira® Peritoneal Drainage System is indicated for intermittent 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 or other symptoms associated with malignant ascites.
The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage.
The Aspira® Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira® Luer/Universal Adapter is intended to provide access to the Aspira® Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira® valve Assembly attaches to the Aspira® Drainage Catheter. The Aspira® Repair Kit is for the repair of the Aspira® Drainage Catheter and replacement of the Aspira® Valve Assembly.
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/K110396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110396: Aspira 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/K110396
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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