510(k) · Cleared
ClearedPleurx Pleural Catheter Systems
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 Feb 16, 2012 as substantially equivalent to K051084 (Denver Biomedicals, Inc., 2005) and 2 other predicates after a 141-day review. Its family tree reaches back 3 generations to 1997. 6 later devices descend from it.
- Decided
- Feb 16, 2012
- Review
- 141 days
- Class
- Class II
- Product code
- DWM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K971753 (1997). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK971753 Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver…Denver Biomaterials, Inc. · 1997
- 2 generations backK071095 Aspira Pleural Drainage SystemBard Access Systems, Inc. · 2007
- 1 generation backK110409 Aspira Pleural Drainage SystemC.R. Bard, Inc. · 2011 · Recalled
- This deviceK112831 Pleurx Pleural Catheter SystemsCare Fusion · 2012
- Descendant · cites it directly · 2 of its ownK123033 Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc…Rocket Medical Plc · 2013
- Descendant · cites it directly · 2 of its ownK121849 Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx…Care Fusion · 2012
- Descendant · 2 generations on · 1 of its ownK141965 Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015
- Descendant · 2 generations on · 0 of its ownK210509 Rocket Platinum Cured CathterRocket Medical Plc · 2021
- Descendant · 2 generations on · 0 of its ownK163321 Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123033Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…Rocket Medical Plc · 2013 · cites it directly2descendants
- K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion · 2012 · cites it directly2descendants
- K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion · 2015 · 2 generations on1descendant
- K210509Rocket Platinum Cured CathterRocket Medical Plc · 2021 · 2 generations on0descendants
- K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971753 | Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home… | Denver Biomaterials, Inc. | 1997 | — |
| −2 | K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | 2007 | — |
| −1 | K110409 | Aspira Pleural Drainage System | C.R. Bard, Inc. | 2011 | 1 |
| 0 (this device) | K112831 | Pleurx Pleural Catheter Systems | Care Fusion | 2012 | — |
| +1 | K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing… | Rocket Medical Plc | 2013 | — |
| +1 | K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter… | Care Fusion | 2012 | — |
| +2 | K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit | Care Fusion | 2015 | — |
| +2 | K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | 2021 | — |
| +2 | K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K051084 | Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage LineSummary page 1…roduct Code(s) Multiple Legally marketed CareFusion Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum device(s) to which Bottle: K051 084 & K052436 equivalence is claimed Bard Aspira Pleural Drainage System. K1 10409 Reason for 510O(k)… | 2005 |
| * | K052436 | Pleurx Pleural Catheter Kit, Model 50-7000Summary page 1…(s) Multiple Legally marketed CareFusion Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum device(s) to which Bottle: K051 084 & K052436 equivalence is claimed Bard Aspira Pleural Drainage System. K1 10409 Reason for 510O(k) Change… | 2005 |
| * | K110409 | Aspira Pleural Drainage SystemSummary page 1…r Pleurx Drainage Kit/Vacuum device(s) to which Bottle: K051 084 & K052436 equivalence is claimed Bard Aspira Pleural Drainage System. K1 10409 Reason for 510O(k) Change to materials, expanding the indications for use, and updates to the submission… | 2011 |
What descends from it? (6)
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 15 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K123033 (Rocket Medical Plc, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K051084.
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 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 Drainage Kits and Drainage Line…
Read the full statement (116 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112831: Pleurx Pleural Catheter Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112831
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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