510(k) · Cleared
ClearedPleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee
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 18, 2012 as substantially equivalent to K112831 (Care Fusion, 2012) and 4 other predicates after a 115-day review. Its family tree reaches back 5 generations to 1993. 2 later devices descend from it.
- Decided
- Oct 18, 2012
- Review
- 115 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K932323 (1993). 21 ancestors in all. 2 later devices descend from it, 1 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 deviceK121849 Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx…Care Fusion · 2012
- Descendant · cites it directly · 1 of its ownK141965 Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015
- Descendant · 2 generations on · 0 of its ownK160450 Pleurx Pleural Catheter SystemCare Fusion · 2016
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 |
|---|---|---|---|---|---|
| −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) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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 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? (5)
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 |
|---|---|---|---|
| * | K112831 | Pleurx Pleural Catheter SystemsSummary page 1…Class 11per 21CFR §870.5050, Procode DWM Product Code(s) Multiple CareFusion Pleurx Catheter Systems: K1 12831 & K1 13854 Legally marketed device(s) to Bard Aspira Pleural Drainage System: K110409 which equivalence is claimed Marte… | 2012 |
| * | K113854 | Pleurx Peritoneal Catheter SystemSummary page 1…Class 11per 21CFR §870.5050, Procode DWM Product Code(s) Multiple CareFusion Pleurx Catheter Systems: K1 12831 & K1 13854 Legally marketed device(s) to Bard Aspira Pleural Drainage System: K110409 which equivalence is claimed Martech (MEOCOMP… | 2012 |
| * | K110409 | Aspira Pleural Drainage SystemSummary page 1…Multiple CareFusion Pleurx Catheter Systems: K1 12831 & K1 13854 Legally marketed device(s) to Bard Aspira Pleural Drainage System: K110409 which equivalence is claimed Martech (MEOCOMP) Valved Tearaway Introducer: K090394 Greatba… | 2011 |
| * | K090394 | Valved Tearway IntroducerSummary page 1…& K1 13854 Legally marketed device(s) to Bard Aspira Pleural Drainage System: K110409 which equivalence is claimed Martech (MEOCOMP) Valved Tearaway Introducer: K090394 Greatbatch (Medmicus) Incorporated FlowGuard Peelable Introducer:… | 2009 |
| * | K040150 | Modification to Medamicus Flowguard Peelable IntroducerSummary page 1…Valved Tearaway Introducer: K090394 Greatbatch (Medmicus) Incorporated FlowGuard Peelable Introducer: K0401 50 Reason for 51 0(k) submission Expanding the indications for use and adding accessories. The Pleurx… | 2004 |
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 |
|---|---|---|---|
| K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit | 2015 | 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 19 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K141965 (Care Fusion, 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K112831.
How does its category compare?
All DWM devicesDWM Apparatus, Suction, Patient Care: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Pldural 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 Drainage Kits and Drainage Line…
Read the full statement (175 words)
The Pleurx Pldural 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 Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx 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 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 pleural space.
The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the pleural space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121849: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121849
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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