510(k) · Cleared
ClearedPleurx Pleural Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · DWM Apparatus, Suction, Patient Care
Cleared on Oct 31, 2016 as substantially equivalent to K141965 (Care Fusion, 2015) and 1 other predicate after a 256-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Oct 31, 2016
- Review
- 256 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K932323 (1993). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 6 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- 5 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- 4 generations backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- 3 generations backK090394 Valved Tearway IntroducerMedcomp · 2009
- 2 generations backK121849 Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx…Care Fusion · 2012
- 1 generation backK141965 Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015
- This deviceK160450 Pleurx Pleural Catheter SystemCare Fusion · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −6 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| −5 | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| −4 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| −3 | K090394 | Valved Tearway Introducer | Medcomp | 2009 | — |
| −2 | K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter… | Care Fusion | 2012 | — |
| −1 | K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit | Care Fusion | 2015 | — |
| 0 (this device) | K160450 | Pleurx Pleural Catheter System | Care Fusion | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 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 DWM? 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 DWM device
- #1 K212696 Aspira Pleural Drainage Systemscore 5.5 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access KitSummary page 4…Class II per 21CFR §870.5050, Procode DWM Product Code(s) Multiple Legally marketed device(s) to CareFusion Pleurx Catheter System: K141965, and which equivalence is claimed Bard Aspira Pleural Drainage System: K110409 This 510(k) sub… | 2015 |
| * | K110409 | Aspira Pleural Drainage SystemSummary page 4…Multiple Legally marketed device(s) to CareFusion Pleurx Catheter System: K141965, and which equivalence is claimed Bard Aspira Pleural Drainage System: K110409 This 510(k) submission is for a change in material formulation and Reason for 510(k) submission… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 2.7 years on median.
- 2 of the 23 ancestors have a recall of any class.
How does its category compare?
All DWM devicesDWM Apparatus, Suction, Patient Care: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DWM
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DWM
Too few DWM 510(k)s in any year since 2007 to give a median.
Recalls per year · DWM
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWM
74in 2025
MAUDE reports naming product code DWM, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 23 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 1 | — | 0 | 78 |
| 2014 | 0 | — | 2 | 94 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 0 | 49 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 0 | — | 0 | 51 |
| 2019 | 1 | — | 0 | 57 |
| 2020 | 1 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 143 |
| 2022 | 0 | — | 0 | 62 |
| 2023 | 1 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 70 |
| 2025 | 0 | — | 0 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PleurX Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion). The PleurX Pleural Catheter Kits are…
Read the full statement (196 words)
The PleurX Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion). The PleurX Pleural Catheter Kits are indicated for adults only.
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 Valve Kit is indicated for adults only.
The PleurX LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX Low Profile Catheter is indicated for adults only.
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/K160450 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160450: Pleurx Pleural 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/K160450
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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